Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02239120




Registration number
NCT02239120
Ethics application status
Date submitted
10/09/2014
Date registered
12/09/2014
Date last updated
6/09/2019

Titles & IDs
Public title
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Scientific title
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Secondary ID [1] 0 0
2013-003444-24
Secondary ID [2] 0 0
1160.189
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Secondary Prevention 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - optional ASA as comedication
Treatment: Drugs - placebo to ASA
Treatment: Drugs - placebo to optional ASA as comedication
Treatment: Drugs - placebo to dabigatran etexilate
Treatment: Drugs - ASA 100 mg
Treatment: Drugs - dabigatran etexilate

Experimental: dabigatran etexilate 110 or 150 mg - Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)

Active comparator: ASA 100 mg - All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d


Treatment: Drugs: optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

Treatment: Drugs: placebo to ASA
placebo to comparator drug

Treatment: Drugs: placebo to optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

Treatment: Drugs: placebo to dabigatran etexilate
placebo

Treatment: Drugs: ASA 100 mg
active comparator drug

Treatment: Drugs: dabigatran etexilate
active drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjudicated Recurrent Stroke
Timepoint [1] 0 0
From randomisation until full follow up period, approximately 43 months.
Primary outcome [2] 0 0
First Major Bleed (Adjudicated)
Timepoint [2] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [1] 0 0
Adjudicated Ischaemic Stroke
Timepoint [1] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [2] 0 0
Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death
Timepoint [2] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [3] 0 0
Disabling Stroke
Timepoint [3] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [4] 0 0
All-cause Death
Timepoint [4] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [5] 0 0
Adjudicated Intracranial Hemorrhage
Timepoint [5] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [6] 0 0
Adjudicated Fatal Bleed
Timepoint [6] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [7] 0 0
Adjudicated Life-threatening Bleed
Timepoint [7] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [8] 0 0
Any Bleed (Investigator-reported)
Timepoint [8] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Eligibility
Key inclusion criteria
Inclusion criteria:

* Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset.
* The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke.
* Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia.
* As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes).

Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
150 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications.
* Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis.
* Any indication that requires treatment with an anticoagulant as per Investigator's judgment.
* History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved).
* Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse).
* Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study.

Further exclusion criteria apply.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/08/2018
Sample size
Target
Accrual to date
Final
5390
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Kanwal Medical Complex - Kanwal
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Calvary North Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [11] 0 0
Austin Health - Heidelberg
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
Alfred Health - Victoria
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2305 - New Lambton
Recruitment postcode(s) [5] 0 0
2038 - St Leonards
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5001 - Adelaide
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3004 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Vermont
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Argentina
State/province [37] 0 0
Caba
Country [38] 0 0
Argentina
State/province [38] 0 0
Cordoba
Country [39] 0 0
Argentina
State/province [39] 0 0
Coronel Suarez
Country [40] 0 0
Argentina
State/province [40] 0 0
Mar del Plata
Country [41] 0 0
Austria
State/province [41] 0 0
Graz
Country [42] 0 0
Austria
State/province [42] 0 0
Innsbruck
Country [43] 0 0
Austria
State/province [43] 0 0
Linz
Country [44] 0 0
Austria
State/province [44] 0 0
Tulln
Country [45] 0 0
Austria
State/province [45] 0 0
Vienna
Country [46] 0 0
Austria
State/province [46] 0 0
Wien
Country [47] 0 0
Belgium
State/province [47] 0 0
Aalst
Country [48] 0 0
Belgium
State/province [48] 0 0
Arlon
Country [49] 0 0
Belgium
State/province [49] 0 0
Brugge
Country [50] 0 0
Belgium
State/province [50] 0 0
Brussel
Country [51] 0 0
Belgium
State/province [51] 0 0
Bruxelles
Country [52] 0 0
Belgium
State/province [52] 0 0
Gent
Country [53] 0 0
Belgium
State/province [53] 0 0
Kortrijk
Country [54] 0 0
Belgium
State/province [54] 0 0
Leuven
Country [55] 0 0
Belgium
State/province [55] 0 0
Liège
Country [56] 0 0
Belgium
State/province [56] 0 0
Roeselare
Country [57] 0 0
Belgium
State/province [57] 0 0
Rumst
Country [58] 0 0
Belgium
State/province [58] 0 0
Sint-Truiden
Country [59] 0 0
Belgium
State/province [59] 0 0
Wilrijk
Country [60] 0 0
Belgium
State/province [60] 0 0
Yvoir
Country [61] 0 0
Brazil
State/province [61] 0 0
Botucatu
Country [62] 0 0
Brazil
State/province [62] 0 0
Curitiba
Country [63] 0 0
Brazil
State/province [63] 0 0
Joinvile
Country [64] 0 0
Brazil
State/province [64] 0 0
Porto Alegre
Country [65] 0 0
Brazil
State/province [65] 0 0
Ribeirao Preto
Country [66] 0 0
Brazil
State/province [66] 0 0
Rio de Janeiro
Country [67] 0 0
Canada
State/province [67] 0 0
Alberta
Country [68] 0 0
Canada
State/province [68] 0 0
Manitoba
Country [69] 0 0
Canada
State/province [69] 0 0
Migration Data
Country [70] 0 0
Canada
State/province [70] 0 0
New Brunswick
Country [71] 0 0
Canada
State/province [71] 0 0
Newfoundland and Labrador
Country [72] 0 0
Canada
State/province [72] 0 0
Ontario
Country [73] 0 0
Canada
State/province [73] 0 0
Quebec
Country [74] 0 0
Chile
State/province [74] 0 0
Santiago
Country [75] 0 0
Chile
State/province [75] 0 0
Temuco
Country [76] 0 0
China
State/province [76] 0 0
Beijing
Country [77] 0 0
China
State/province [77] 0 0
Changchun
Country [78] 0 0
China
State/province [78] 0 0
Guangzhou
Country [79] 0 0
China
State/province [79] 0 0
Guiyang
Country [80] 0 0
China
State/province [80] 0 0
Hangzhou
Country [81] 0 0
China
State/province [81] 0 0
Jilin
Country [82] 0 0
China
State/province [82] 0 0
Nanchang
Country [83] 0 0
China
State/province [83] 0 0
Nanjing
Country [84] 0 0
China
State/province [84] 0 0
Qingdao
Country [85] 0 0
China
State/province [85] 0 0
Shanghai
Country [86] 0 0
China
State/province [86] 0 0
Shenyang
Country [87] 0 0
China
State/province [87] 0 0
Xiamen
Country [88] 0 0
China
State/province [88] 0 0
Xuzhou
Country [89] 0 0
Colombia
State/province [89] 0 0
Bogotá
Country [90] 0 0
Colombia
State/province [90] 0 0
Cali
Country [91] 0 0
Colombia
State/province [91] 0 0
Floridablanca
Country [92] 0 0
Croatia
State/province [92] 0 0
Varazdin
Country [93] 0 0
Croatia
State/province [93] 0 0
Zagreb
Country [94] 0 0
Czechia
State/province [94] 0 0
Brno
Country [95] 0 0
Czechia
State/province [95] 0 0
Jihlava
Country [96] 0 0
Czechia
State/province [96] 0 0
Olomouc
Country [97] 0 0
Czechia
State/province [97] 0 0
Ostrava
Country [98] 0 0
Czechia
State/province [98] 0 0
Prague 5
Country [99] 0 0
Czechia
State/province [99] 0 0
Praha 5
Country [100] 0 0
Estonia
State/province [100] 0 0
Ahtme
Country [101] 0 0
Estonia
State/province [101] 0 0
Tallinn
Country [102] 0 0
Estonia
State/province [102] 0 0
Tartu
Country [103] 0 0
France
State/province [103] 0 0
Aix en Provence
Country [104] 0 0
France
State/province [104] 0 0
Bayonne
Country [105] 0 0
France
State/province [105] 0 0
Besançon
Country [106] 0 0
France
State/province [106] 0 0
Bordeaux
Country [107] 0 0
France
State/province [107] 0 0
Brest
Country [108] 0 0
France
State/province [108] 0 0
Bron
Country [109] 0 0
France
State/province [109] 0 0
Caen
Country [110] 0 0
France
State/province [110] 0 0
Grenoble
Country [111] 0 0
France
State/province [111] 0 0
Lille
Country [112] 0 0
France
State/province [112] 0 0
Metz
Country [113] 0 0
France
State/province [113] 0 0
Paris
Country [114] 0 0
France
State/province [114] 0 0
Toulouse
Country [115] 0 0
Germany
State/province [115] 0 0
Altenburg
Country [116] 0 0
Germany
State/province [116] 0 0
Bad Neustadt
Country [117] 0 0
Germany
State/province [117] 0 0
Berlin
Country [118] 0 0
Germany
State/province [118] 0 0
Bielefeld
Country [119] 0 0
Germany
State/province [119] 0 0
Bochum
Country [120] 0 0
Germany
State/province [120] 0 0
Bremen
Country [121] 0 0
Germany
State/province [121] 0 0
Buchholz
Country [122] 0 0
Germany
State/province [122] 0 0
Celle
Country [123] 0 0
Germany
State/province [123] 0 0
Chemnitz
Country [124] 0 0
Germany
State/province [124] 0 0
Coburg
Country [125] 0 0
Germany
State/province [125] 0 0
Dortmund
Country [126] 0 0
Germany
State/province [126] 0 0
Dresden
Country [127] 0 0
Germany
State/province [127] 0 0
Düsseldorf
Country [128] 0 0
Germany
State/province [128] 0 0
Erlangen
Country [129] 0 0
Germany
State/province [129] 0 0
Essen
Country [130] 0 0
Germany
State/province [130] 0 0
Frankfurt am Main
Country [131] 0 0
Germany
State/province [131] 0 0
Frankfurt
Country [132] 0 0
Germany
State/province [132] 0 0
Friedrichshafen
Country [133] 0 0
Germany
State/province [133] 0 0
Fulda
Country [134] 0 0
Germany
State/province [134] 0 0
Gelsenkirchen
Country [135] 0 0
Germany
State/province [135] 0 0
Gera
Country [136] 0 0
Germany
State/province [136] 0 0
Gießen
Country [137] 0 0
Germany
State/province [137] 0 0
Greifswald
Country [138] 0 0
Germany
State/province [138] 0 0
Günzburg
Country [139] 0 0
Germany
State/province [139] 0 0
Hamburg
Country [140] 0 0
Germany
State/province [140] 0 0
Hanau
Country [141] 0 0
Germany
State/province [141] 0 0
Hannover
Country [142] 0 0
Germany
State/province [142] 0 0
Heidelberg
Country [143] 0 0
Germany
State/province [143] 0 0
Heilbronn
Country [144] 0 0
Germany
State/province [144] 0 0
Idar-Oberstein
Country [145] 0 0
Germany
State/province [145] 0 0
Jena
Country [146] 0 0
Germany
State/province [146] 0 0
Kiel
Country [147] 0 0
Germany
State/province [147] 0 0
Köln
Country [148] 0 0
Germany
State/province [148] 0 0
Leipzig
Country [149] 0 0
Germany
State/province [149] 0 0
Ludwigshafen
Country [150] 0 0
Germany
State/province [150] 0 0
Magdeburg
Country [151] 0 0
Germany
State/province [151] 0 0
Mainz
Country [152] 0 0
Germany
State/province [152] 0 0
Marburg
Country [153] 0 0
Germany
State/province [153] 0 0
Meißen
Country [154] 0 0
Germany
State/province [154] 0 0
Minden
Country [155] 0 0
Germany
State/province [155] 0 0
Moenchengladbach
Country [156] 0 0
Germany
State/province [156] 0 0
Mühlhausen
Country [157] 0 0
Germany
State/province [157] 0 0
München
Country [158] 0 0
Germany
State/province [158] 0 0
Münster
Country [159] 0 0
Germany
State/province [159] 0 0
Nürnberg
Country [160] 0 0
Germany
State/province [160] 0 0
Offenbach
Country [161] 0 0
Germany
State/province [161] 0 0
Osnabrück
Country [162] 0 0
Germany
State/province [162] 0 0
Regensburg
Country [163] 0 0
Germany
State/province [163] 0 0
Sande
Country [164] 0 0
Germany
State/province [164] 0 0
Siegen
Country [165] 0 0
Germany
State/province [165] 0 0
Stuttgart
Country [166] 0 0
Germany
State/province [166] 0 0
Teupitz
Country [167] 0 0
Germany
State/province [167] 0 0
Trier
Country [168] 0 0
Germany
State/province [168] 0 0
Tübingen
Country [169] 0 0
Germany
State/province [169] 0 0
Ulm
Country [170] 0 0
Germany
State/province [170] 0 0
Weimar
Country [171] 0 0
Germany
State/province [171] 0 0
Wiesbaden
Country [172] 0 0
Germany
State/province [172] 0 0
Würzburg
Country [173] 0 0
Greece
State/province [173] 0 0
Alexandroupolis
Country [174] 0 0
Greece
State/province [174] 0 0
Athens
Country [175] 0 0
Greece
State/province [175] 0 0
Herakleion
Country [176] 0 0
Greece
State/province [176] 0 0
Larissa
Country [177] 0 0
Greece
State/province [177] 0 0
Patras
Country [178] 0 0
Greece
State/province [178] 0 0
Thessaloniki
Country [179] 0 0
Hong Kong
State/province [179] 0 0
Hong Kong
Country [180] 0 0
Hungary
State/province [180] 0 0
Budapest
Country [181] 0 0
Hungary
State/province [181] 0 0
Debrecen
Country [182] 0 0
Hungary
State/province [182] 0 0
Kistarcsa
Country [183] 0 0
Hungary
State/province [183] 0 0
Miskolc
Country [184] 0 0
Hungary
State/province [184] 0 0
Pecs
Country [185] 0 0
India
State/province [185] 0 0
Bangalore
Country [186] 0 0
India
State/province [186] 0 0
Chandigarh
Country [187] 0 0
India
State/province [187] 0 0
Guntur
Country [188] 0 0
India
State/province [188] 0 0
Hyderabad
Country [189] 0 0
India
State/province [189] 0 0
Karamsad
Country [190] 0 0
India
State/province [190] 0 0
Kottayam
Country [191] 0 0
India
State/province [191] 0 0
Mangalore
Country [192] 0 0
India
State/province [192] 0 0
Mumbai
Country [193] 0 0
India
State/province [193] 0 0
Nashik
Country [194] 0 0
India
State/province [194] 0 0
New Delhi
Country [195] 0 0
India
State/province [195] 0 0
Pune
Country [196] 0 0
Israel
State/province [196] 0 0
Hadera
Country [197] 0 0
Israel
State/province [197] 0 0
Holon
Country [198] 0 0
Israel
State/province [198] 0 0
Tel Hashomer, Ramat Gan
Country [199] 0 0
Israel
State/province [199] 0 0
Telaviv
Country [200] 0 0
Italy
State/province [200] 0 0
Avezzano
Country [201] 0 0
Italy
State/province [201] 0 0
Bologna
Country [202] 0 0
Italy
State/province [202] 0 0
Brescia
Country [203] 0 0
Italy
State/province [203] 0 0
Cona (FE)
Country [204] 0 0
Italy
State/province [204] 0 0
Genova
Country [205] 0 0
Italy
State/province [205] 0 0
Messina
Country [206] 0 0
Italy
State/province [206] 0 0
Milano
Country [207] 0 0
Italy
State/province [207] 0 0
Modena
Country [208] 0 0
Italy
State/province [208] 0 0
Padova
Country [209] 0 0
Italy
State/province [209] 0 0
Perugia
Country [210] 0 0
Italy
State/province [210] 0 0
Piacenza
Country [211] 0 0
Italy
State/province [211] 0 0
Pietra Ligure
Country [212] 0 0
Italy
State/province [212] 0 0
Roma
Country [213] 0 0
Italy
State/province [213] 0 0
Siena
Country [214] 0 0
Italy
State/province [214] 0 0
Torino
Country [215] 0 0
Italy
State/province [215] 0 0
Treviso
Country [216] 0 0
Italy
State/province [216] 0 0
Varese
Country [217] 0 0
Italy
State/province [217] 0 0
Verona
Country [218] 0 0
Japan
State/province [218] 0 0
Aichi, Nagoya
Country [219] 0 0
Japan
State/province [219] 0 0
Aichi, Toyohashi
Country [220] 0 0
Japan
State/province [220] 0 0
Aichi, Toyota
Country [221] 0 0
Japan
State/province [221] 0 0
Akita, Akita
Country [222] 0 0
Japan
State/province [222] 0 0
Chiba, Urayasu
Country [223] 0 0
Japan
State/province [223] 0 0
Fukuoka, Chikushi-gun
Country [224] 0 0
Japan
State/province [224] 0 0
Fukuoka, Chikushino
Country [225] 0 0
Japan
State/province [225] 0 0
Fukuoka, Fukuoka
Country [226] 0 0
Japan
State/province [226] 0 0
Fukuoka, Kasuga
Country [227] 0 0
Japan
State/province [227] 0 0
Fukuoka, Kitakyushu
Country [228] 0 0
Japan
State/province [228] 0 0
Fukuoka, Kurume
Country [229] 0 0
Japan
State/province [229] 0 0
Fukuoka, Onga
Country [230] 0 0
Japan
State/province [230] 0 0
Fukuoka, Tagawa
Country [231] 0 0
Japan
State/province [231] 0 0
Fukuoka, Yukuhashi
Country [232] 0 0
Japan
State/province [232] 0 0
Fukushima, Date-Gun
Country [233] 0 0
Japan
State/province [233] 0 0
Fukushima, Nihonmatsu
Country [234] 0 0
Japan
State/province [234] 0 0
Gifu, Gifu
Country [235] 0 0
Japan
State/province [235] 0 0
Gifu, Takayama
Country [236] 0 0
Japan
State/province [236] 0 0
Gunma, Isesaki
Country [237] 0 0
Japan
State/province [237] 0 0
Gunma, Maebashi
Country [238] 0 0
Japan
State/province [238] 0 0
Hiroshima, Hiroshima
Country [239] 0 0
Japan
State/province [239] 0 0
Hokkaido, Sapporo
Country [240] 0 0
Japan
State/province [240] 0 0
Hyogo, Kobe
Country [241] 0 0
Japan
State/province [241] 0 0
Ibaraki, Toride
Country [242] 0 0
Japan
State/province [242] 0 0
Ibaraki, Tsukuba
Country [243] 0 0
Japan
State/province [243] 0 0
Iwate, Morioka
Country [244] 0 0
Japan
State/province [244] 0 0
Kagoshima, Kagoshima
Country [245] 0 0
Japan
State/province [245] 0 0
Kanagawa, Kamakura
Country [246] 0 0
Japan
State/province [246] 0 0
Kumamoto, Kumamoto
Country [247] 0 0
Japan
State/province [247] 0 0
Kyoto, Uji
Country [248] 0 0
Japan
State/province [248] 0 0
Miyagi, Sendai
Country [249] 0 0
Japan
State/province [249] 0 0
Miyagi, Shibata-gun
Country [250] 0 0
Japan
State/province [250] 0 0
Nagano, Ina
Country [251] 0 0
Japan
State/province [251] 0 0
Nagano, Naganoi
Country [252] 0 0
Japan
State/province [252] 0 0
Nagasaki, Nagasaki
Country [253] 0 0
Japan
State/province [253] 0 0
Osaka, Daito
Country [254] 0 0
Japan
State/province [254] 0 0
Osaka, Higashiosaka
Country [255] 0 0
Japan
State/province [255] 0 0
Osaka, Izumisano
Country [256] 0 0
Japan
State/province [256] 0 0
Osaka, Kishiwada
Country [257] 0 0
Japan
State/province [257] 0 0
Osaka, Osaka
Country [258] 0 0
Japan
State/province [258] 0 0
Osaka, Suita
Country [259] 0 0
Japan
State/province [259] 0 0
Saitama, Asaka
Country [260] 0 0
Japan
State/province [260] 0 0
Saitama, Hidaka
Country [261] 0 0
Japan
State/province [261] 0 0
Saitama, Saitama
Country [262] 0 0
Japan
State/province [262] 0 0
Tokyo, Bunkyo-ku
Country [263] 0 0
Japan
State/province [263] 0 0
Tokyo, Itabashi-ku
Country [264] 0 0
Japan
State/province [264] 0 0
Tokyo, Mitaka
Country [265] 0 0
Japan
State/province [265] 0 0
Tokyo, Shinjuku-ku
Country [266] 0 0
Japan
State/province [266] 0 0
Wakayama, Wakayama
Country [267] 0 0
Japan
State/province [267] 0 0
Yamagata, Yamagata
Country [268] 0 0
Korea, Republic of
State/province [268] 0 0
Anyang
Country [269] 0 0
Korea, Republic of
State/province [269] 0 0
Busan
Country [270] 0 0
Korea, Republic of
State/province [270] 0 0
Daegu
Country [271] 0 0
Korea, Republic of
State/province [271] 0 0
Daejoen
Country [272] 0 0
Korea, Republic of
State/province [272] 0 0
Goyang
Country [273] 0 0
Korea, Republic of
State/province [273] 0 0
Gwangju
Country [274] 0 0
Korea, Republic of
State/province [274] 0 0
Seongnam
Country [275] 0 0
Korea, Republic of
State/province [275] 0 0
Seoul
Country [276] 0 0
Korea, Republic of
State/province [276] 0 0
Suwon
Country [277] 0 0
Malaysia
State/province [277] 0 0
Kuching
Country [278] 0 0
Malaysia
State/province [278] 0 0
Pulau Pinang
Country [279] 0 0
Malaysia
State/province [279] 0 0
Terengganu
Country [280] 0 0
Mexico
State/province [280] 0 0
Culiacán
Country [281] 0 0
Mexico
State/province [281] 0 0
Morelia
Country [282] 0 0
Mexico
State/province [282] 0 0
México, D.F.
Country [283] 0 0
Mexico
State/province [283] 0 0
Nuevo Leon
Country [284] 0 0
Mexico
State/province [284] 0 0
San Luis Potosi
Country [285] 0 0
New Zealand
State/province [285] 0 0
Grafton / Auckland
Country [286] 0 0
New Zealand
State/province [286] 0 0
Takpuna Auckland
Country [287] 0 0
New Zealand
State/province [287] 0 0
Wellington
Country [288] 0 0
Peru
State/province [288] 0 0
Barrios Altos
Country [289] 0 0
Peru
State/province [289] 0 0
La Victoria
Country [290] 0 0
Poland
State/province [290] 0 0
Gdansk
Country [291] 0 0
Poland
State/province [291] 0 0
Grudziadz
Country [292] 0 0
Poland
State/province [292] 0 0
Katowice
Country [293] 0 0
Poland
State/province [293] 0 0
Krakow
Country [294] 0 0
Poland
State/province [294] 0 0
Lublin
Country [295] 0 0
Poland
State/province [295] 0 0
Oswiecim
Country [296] 0 0
Poland
State/province [296] 0 0
Sandomierz
Country [297] 0 0
Poland
State/province [297] 0 0
Warsaw
Country [298] 0 0
Portugal
State/province [298] 0 0
Almada
Country [299] 0 0
Portugal
State/province [299] 0 0
Amadora
Country [300] 0 0
Portugal
State/province [300] 0 0
Braga
Country [301] 0 0
Portugal
State/province [301] 0 0
Coimbra
Country [302] 0 0
Portugal
State/province [302] 0 0
Lisboa
Country [303] 0 0
Portugal
State/province [303] 0 0
Loures
Country [304] 0 0
Portugal
State/province [304] 0 0
Matosinhos
Country [305] 0 0
Portugal
State/province [305] 0 0
Porto
Country [306] 0 0
Portugal
State/province [306] 0 0
Santa Maria da Feira
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Kazan
Country [308] 0 0
Russian Federation
State/province [308] 0 0
Krasnodar
Country [309] 0 0
Russian Federation
State/province [309] 0 0
Kursk
Country [310] 0 0
Russian Federation
State/province [310] 0 0
Moscow
Country [311] 0 0
Russian Federation
State/province [311] 0 0
Novosibirsk
Country [312] 0 0
Russian Federation
State/province [312] 0 0
Saratov
Country [313] 0 0
Russian Federation
State/province [313] 0 0
Smolensk
Country [314] 0 0
Russian Federation
State/province [314] 0 0
St. Petersburg
Country [315] 0 0
Russian Federation
State/province [315] 0 0
Yekaterinburg
Country [316] 0 0
Serbia
State/province [316] 0 0
Belgrade
Country [317] 0 0
Serbia
State/province [317] 0 0
Nis
Country [318] 0 0
Serbia
State/province [318] 0 0
Novi Sad
Country [319] 0 0
Singapore
State/province [319] 0 0
Singapore
Country [320] 0 0
Slovakia
State/province [320] 0 0
Kosice
Country [321] 0 0
Slovakia
State/province [321] 0 0
Nitra
Country [322] 0 0
Slovenia
State/province [322] 0 0
Dobrna
Country [323] 0 0
Slovenia
State/province [323] 0 0
Ljubljana
Country [324] 0 0
Slovenia
State/province [324] 0 0
Maribor
Country [325] 0 0
South Africa
State/province [325] 0 0
Pretoria
Country [326] 0 0
South Africa
State/province [326] 0 0
Tongaat
Country [327] 0 0
Spain
State/province [327] 0 0
Albacete
Country [328] 0 0
Spain
State/province [328] 0 0
Barcelona
Country [329] 0 0
Spain
State/province [329] 0 0
Girona
Country [330] 0 0
Spain
State/province [330] 0 0
Lleida
Country [331] 0 0
Spain
State/province [331] 0 0
Madrid
Country [332] 0 0
Spain
State/province [332] 0 0
Palma de Mallorca
Country [333] 0 0
Spain
State/province [333] 0 0
Pamplona
Country [334] 0 0
Spain
State/province [334] 0 0
San Sebastian
Country [335] 0 0
Spain
State/province [335] 0 0
Santiago de Compostela
Country [336] 0 0
Spain
State/province [336] 0 0
Sevilla
Country [337] 0 0
Spain
State/province [337] 0 0
Tarragona
Country [338] 0 0
Spain
State/province [338] 0 0
Tarrasa (Barcelona)
Country [339] 0 0
Spain
State/province [339] 0 0
Valencia
Country [340] 0 0
Spain
State/province [340] 0 0
Valladolid
Country [341] 0 0
Sweden
State/province [341] 0 0
Göteborg
Country [342] 0 0
Sweden
State/province [342] 0 0
Skövde
Country [343] 0 0
Sweden
State/province [343] 0 0
Stockholm
Country [344] 0 0
Switzerland
State/province [344] 0 0
Aarau
Country [345] 0 0
Switzerland
State/province [345] 0 0
Basel
Country [346] 0 0
Switzerland
State/province [346] 0 0
Bern
Country [347] 0 0
Switzerland
State/province [347] 0 0
Lausanne
Country [348] 0 0
Switzerland
State/province [348] 0 0
Lugano
Country [349] 0 0
Switzerland
State/province [349] 0 0
St. Gallen
Country [350] 0 0
Switzerland
State/province [350] 0 0
Zürich
Country [351] 0 0
Taiwan
State/province [351] 0 0
Changhua
Country [352] 0 0
Taiwan
State/province [352] 0 0
Kaohsiung
Country [353] 0 0
Taiwan
State/province [353] 0 0
Taichung
Country [354] 0 0
Taiwan
State/province [354] 0 0
Tainan,
Country [355] 0 0
Taiwan
State/province [355] 0 0
Tainan
Country [356] 0 0
Taiwan
State/province [356] 0 0
Taipei
Country [357] 0 0
Taiwan
State/province [357] 0 0
Taoyuan
Country [358] 0 0
Thailand
State/province [358] 0 0
Bangkok
Country [359] 0 0
Thailand
State/province [359] 0 0
Lampang
Country [360] 0 0
Turkey
State/province [360] 0 0
Ankara
Country [361] 0 0
Turkey
State/province [361] 0 0
Eskisehir
Country [362] 0 0
Turkey
State/province [362] 0 0
Istanbul
Country [363] 0 0
Turkey
State/province [363] 0 0
Izmir
Country [364] 0 0
Turkey
State/province [364] 0 0
Samsun
Country [365] 0 0
Turkey
State/province [365] 0 0
Tekirdag
Country [366] 0 0
Ukraine
State/province [366] 0 0
Chernivtsi
Country [367] 0 0
Ukraine
State/province [367] 0 0
Kharkiv
Country [368] 0 0
Ukraine
State/province [368] 0 0
Kyiv
Country [369] 0 0
Ukraine
State/province [369] 0 0
Lviv
Country [370] 0 0
Ukraine
State/province [370] 0 0
Ternopil
Country [371] 0 0
Ukraine
State/province [371] 0 0
Vinnitsia
Country [372] 0 0
Ukraine
State/province [372] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02239120