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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00262600




Registration number
NCT00262600
Ethics application status
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
17/04/2019

Titles & IDs
Public title
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Scientific title
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Secondary ID [1] 0 0
2005-003894-26
Secondary ID [2] 0 0
1160.26
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - warfarin
Treatment: Drugs - Dabigatran dose 1
Treatment: Drugs - Dabigatran dose 2

Active comparator: Dabigatran dose 2 - twice a day

Active comparator: Warfarin - once a day

Active comparator: Dabigatran dose 1 - twice a day


Treatment: Drugs: warfarin
once a day

Treatment: Drugs: Dabigatran dose 1
twice daily

Treatment: Drugs: Dabigatran dose 2
twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Yearly Event Rate for Composite Endpoint of Stroke/SEE
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Bleeding Events (Major and Minor)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Abnormal Liver Function Test
Timepoint [5] 0 0
36 months

Eligibility
Key inclusion criteria
Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
3. Conditions associated with an increased risk of bleeding
4. Contraindication to warfarin treatment
5. Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
6. Plan to perform a pulmonary vein ablation or surgery for cure of the AF
7. Severe renal impairment (estimated creatinine clearance <=30 mL/min)
8. Active infective endocarditis
9. Active liver disease
10. Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
11. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
12. Patients who have developed transaminase elevations upon exposure to ximelagatran
13. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
14. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
15. Any known hypersensitivity to galactose if the warfarin used contains galactose.

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?



Intervention assignment
Parallel
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
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
18113
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
1160.26.0508 Boehringer Ingelheim Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
1160.26.0510 Boehringer Ingelheim Investigational Site - Gosford
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1160.26.0505 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [4] 0 0
1160.26.0506 Boehringer Ingelheim Investigational Site - Milton
Recruitment hospital [5] 0 0
1160.26.0509 Boehringer Ingelheim Investigational Site - Ashford
Recruitment hospital [6] 0 0
1160.26.0507 Boehringer Ingelheim Investigational Site - Launceston
Recruitment hospital [7] 0 0
1160.26.0504 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
1160.26.0501 Boehringer Ingelheim Investigational Site - Geelong
Recruitment hospital [9] 0 0
1160.26.0502 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [10] 0 0
1160.26.0503 Boehringer Ingelheim Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
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- Gosford
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- Herston
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- Milton
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- Ashford
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- Launceston
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- Box Hill
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- Geelong
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- Parkville
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- Prahran
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State/province [214] 0 0
Hadera
Country [215] 0 0
Israel
State/province [215] 0 0
Haifa
Country [216] 0 0
Israel
State/province [216] 0 0
Holon
Country [217] 0 0
Israel
State/province [217] 0 0
Jerusalem
Country [218] 0 0
Israel
State/province [218] 0 0
Kfar Saba
Country [219] 0 0
Israel
State/province [219] 0 0
Nazareth
Country [220] 0 0
Israel
State/province [220] 0 0
Petah Tikva
Country [221] 0 0
Israel
State/province [221] 0 0
Ramat Gan
Country [222] 0 0
Israel
State/province [222] 0 0
Rehovot
Country [223] 0 0
Israel
State/province [223] 0 0
Safed
Country [224] 0 0
Israel
State/province [224] 0 0
Tel Hashomer
Country [225] 0 0
Israel
State/province [225] 0 0
Tel-Aviv
Country [226] 0 0
Israel
State/province [226] 0 0
Zerifin
Country [227] 0 0
Italy
State/province [227] 0 0
Arezzo
Country [228] 0 0
Italy
State/province [228] 0 0
Ascoli Piceno
Country [229] 0 0
Italy
State/province [229] 0 0
Bentivoglio (BO)
Country [230] 0 0
Italy
State/province [230] 0 0
Bologna
Country [231] 0 0
Italy
State/province [231] 0 0
Castelnuovo Garfagnana
Country [232] 0 0
Italy
State/province [232] 0 0
Chieti
Country [233] 0 0
Italy
State/province [233] 0 0
Colleferro
Country [234] 0 0
Italy
State/province [234] 0 0
Cremona
Country [235] 0 0
Italy
State/province [235] 0 0
Eboli
Country [236] 0 0
Italy
State/province [236] 0 0
Isernia
Country [237] 0 0
Italy
State/province [237] 0 0
Legnago
Country [238] 0 0
Italy
State/province [238] 0 0
Mantova
Country [239] 0 0
Italy
State/province [239] 0 0
Perugia SAN Sisto
Country [240] 0 0
Italy
State/province [240] 0 0
Roma
Country [241] 0 0
Italy
State/province [241] 0 0
San Bonifacio
Country [242] 0 0
Italy
State/province [242] 0 0
San Daniele Del Friuli
Country [243] 0 0
Italy
State/province [243] 0 0
Sassari
Country [244] 0 0
Japan
State/province [244] 0 0
Abeno-ku, Osaka, Osaka
Country [245] 0 0
Japan
State/province [245] 0 0
Aki-gun, Hiroshima
Country [246] 0 0
Japan
State/province [246] 0 0
Aoba-ku, Sendai, Miyagi
Country [247] 0 0
Japan
State/province [247] 0 0
Chuo-ku, Fukuoka, Fukuoka
Country [248] 0 0
Japan
State/province [248] 0 0
Chuo-ku, Kobe, Hyogo
Country [249] 0 0
Japan
State/province [249] 0 0
Chuo-ku, Osaka, Osaka
Country [250] 0 0
Japan
State/province [250] 0 0
Fujioka-shi , Gunma-ken
Country [251] 0 0
Japan
State/province [251] 0 0
Fukushima-shi,Fukushima-ken
Country [252] 0 0
Japan
State/province [252] 0 0
Higashimatsushimashi, Miyagi-ken
Country [253] 0 0
Japan
State/province [253] 0 0
Himeji, Hyogo
Country [254] 0 0
Japan
State/province [254] 0 0
Iida, Nagano
Country [255] 0 0
Japan
State/province [255] 0 0
Isesaki-shi,Gunma
Country [256] 0 0
Japan
State/province [256] 0 0
Iwakuni, Yamaguchi
Country [257] 0 0
Japan
State/province [257] 0 0
Izumi-ku, Sendai, Miyagi
Country [258] 0 0
Japan
State/province [258] 0 0
Kamigyo-ku, Kyoto
Country [259] 0 0
Japan
State/province [259] 0 0
Kawachinagano, Osaka
Country [260] 0 0
Japan
State/province [260] 0 0
Kita-ku, Osaka, Osaka
Country [261] 0 0
Japan
State/province [261] 0 0
Kita-ku, Sakai, Osaka
Country [262] 0 0
Japan
State/province [262] 0 0
Komatsu-shi,Ishikawa -ken
Country [263] 0 0
Japan
State/province [263] 0 0
Kyoto-shi,Kyoto
Country [264] 0 0
Japan
State/province [264] 0 0
Matsumoto, Nagano
Country [265] 0 0
Japan
State/province [265] 0 0
Minami-ku, Fukuoka, Fukuoka
Country [266] 0 0
Japan
State/province [266] 0 0
Minato, Tokyo
Country [267] 0 0
Japan
State/province [267] 0 0
Minato-ku, Nagoya, Aichi
Country [268] 0 0
Japan
State/province [268] 0 0
Narashino, Chiba
Country [269] 0 0
Japan
State/province [269] 0 0
Nishinomiya-shi,Hyogo
Country [270] 0 0
Japan
State/province [270] 0 0
Okayama, Okayama
Country [271] 0 0
Japan
State/province [271] 0 0
Oota, Tokyo
Country [272] 0 0
Japan
State/province [272] 0 0
Otaru, Hokkaido
Country [273] 0 0
Japan
State/province [273] 0 0
Sagamihara, Kanagawa-ken
Country [274] 0 0
Japan
State/province [274] 0 0
Sapporo-shi,Hokkai-do
Country [275] 0 0
Japan
State/province [275] 0 0
Shibuya, Tokyo
Country [276] 0 0
Japan
State/province [276] 0 0
Shinjuku, Tokyo
Country [277] 0 0
Japan
State/province [277] 0 0
Shiroishi-ku, Sapporo, Hokkaido
Country [278] 0 0
Japan
State/province [278] 0 0
Suita, Osaka
Country [279] 0 0
Japan
State/province [279] 0 0
Suita-shi, Osaka
Country [280] 0 0
Japan
State/province [280] 0 0
Sumiyoshi-ku, Osaka, Osaka
Country [281] 0 0
Japan
State/province [281] 0 0
Takatsuki-shi,Osaka
Country [282] 0 0
Japan
State/province [282] 0 0
Tokorozawa, Saitama
Country [283] 0 0
Japan
State/province [283] 0 0
Totsuka-ku, Yokohama, Kanagawa
Country [284] 0 0
Japan
State/province [284] 0 0
Tsuchiura, Ibaragi
Country [285] 0 0
Japan
State/province [285] 0 0
Ueda, Nagano
Country [286] 0 0
Japan
State/province [286] 0 0
Wakayama, Wakayama
Country [287] 0 0
Japan
State/province [287] 0 0
Yanagawa, Fukuoka
Country [288] 0 0
Japan
State/province [288] 0 0
Yao, Osaka
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Busan
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Chungchungnam-Do
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Daegu
Country [292] 0 0
Korea, Republic of
State/province [292] 0 0
Gwangju
Country [293] 0 0
Korea, Republic of
State/province [293] 0 0
Incheon
Country [294] 0 0
Korea, Republic of
State/province [294] 0 0
Seoul
Country [295] 0 0
Malaysia
State/province [295] 0 0
Kajang,Selangor
Country [296] 0 0
Malaysia
State/province [296] 0 0
Kuala Lumpur
Country [297] 0 0
Malaysia
State/province [297] 0 0
Kuching
Country [298] 0 0
Malaysia
State/province [298] 0 0
Penang
Country [299] 0 0
Mexico
State/province [299] 0 0
Durango
Country [300] 0 0
Mexico
State/province [300] 0 0
Guadalajara
Country [301] 0 0
Mexico
State/province [301] 0 0
Mexico
Country [302] 0 0
Mexico
State/province [302] 0 0
México
Country [303] 0 0
Mexico
State/province [303] 0 0
San Luis Potosí
Country [304] 0 0
Netherlands
State/province [304] 0 0
Almelo
Country [305] 0 0
Netherlands
State/province [305] 0 0
Amsterdam
Country [306] 0 0
Netherlands
State/province [306] 0 0
Apeldoorn
Country [307] 0 0
Netherlands
State/province [307] 0 0
Breda
Country [308] 0 0
Netherlands
State/province [308] 0 0
Den Bosch
Country [309] 0 0
Netherlands
State/province [309] 0 0
Den Helder
Country [310] 0 0
Netherlands
State/province [310] 0 0
Deventer
Country [311] 0 0
Netherlands
State/province [311] 0 0
Dirksland
Country [312] 0 0
Netherlands
State/province [312] 0 0
Dordrecht
Country [313] 0 0
Netherlands
State/province [313] 0 0
Ede
Country [314] 0 0
Netherlands
State/province [314] 0 0
Eindhoven
Country [315] 0 0
Netherlands
State/province [315] 0 0
Enschede
Country [316] 0 0
Netherlands
State/province [316] 0 0
Goes
Country [317] 0 0
Netherlands
State/province [317] 0 0
Gorinchem
Country [318] 0 0
Netherlands
State/province [318] 0 0
Groningen
Country [319] 0 0
Netherlands
State/province [319] 0 0
Heerlen
Country [320] 0 0
Netherlands
State/province [320] 0 0
Hengelo
Country [321] 0 0
Netherlands
State/province [321] 0 0
Hilversum
Country [322] 0 0
Netherlands
State/province [322] 0 0
Hoorn
Country [323] 0 0
Netherlands
State/province [323] 0 0
Maastricht
Country [324] 0 0
Netherlands
State/province [324] 0 0
Meppel
Country [325] 0 0
Netherlands
State/province [325] 0 0
Rotterdam
Country [326] 0 0
Netherlands
State/province [326] 0 0
Sneek
Country [327] 0 0
Netherlands
State/province [327] 0 0
Spiijkenisse
Country [328] 0 0
Netherlands
State/province [328] 0 0
Terneuzen
Country [329] 0 0
Netherlands
State/province [329] 0 0
Tiel
Country [330] 0 0
Netherlands
State/province [330] 0 0
Tilburg
Country [331] 0 0
Netherlands
State/province [331] 0 0
Veldhoven
Country [332] 0 0
Netherlands
State/province [332] 0 0
Velp
Country [333] 0 0
Netherlands
State/province [333] 0 0
Venlo
Country [334] 0 0
Norway
State/province [334] 0 0
Gjøvik
Country [335] 0 0
Norway
State/province [335] 0 0
Moss
Country [336] 0 0
Norway
State/province [336] 0 0
Nordbyhagen
Country [337] 0 0
Norway
State/province [337] 0 0
Oslo
Country [338] 0 0
Norway
State/province [338] 0 0
RUD
Country [339] 0 0
Peru
State/province [339] 0 0
Bella Vista
Country [340] 0 0
Peru
State/province [340] 0 0
Jesús María
Country [341] 0 0
Peru
State/province [341] 0 0
San Isidro
Country [342] 0 0
Peru
State/province [342] 0 0
San Martín de Porres
Country [343] 0 0
Peru
State/province [343] 0 0
Urbanización Sto Tomas De San Borja
Country [344] 0 0
Philippines
State/province [344] 0 0
Manila
Country [345] 0 0
Philippines
State/province [345] 0 0
Pasig City
Country [346] 0 0
Philippines
State/province [346] 0 0
Quezon City
Country [347] 0 0
Poland
State/province [347] 0 0
Gdynia Redlowo
Country [348] 0 0
Poland
State/province [348] 0 0
Gdynia
Country [349] 0 0
Poland
State/province [349] 0 0
Katowice
Country [350] 0 0
Poland
State/province [350] 0 0
Krakow
Country [351] 0 0
Poland
State/province [351] 0 0
Pulawy
Country [352] 0 0
Poland
State/province [352] 0 0
Warsaw
Country [353] 0 0
Poland
State/province [353] 0 0
Zabrze
Country [354] 0 0
Portugal
State/province [354] 0 0
Amadora
Country [355] 0 0
Portugal
State/province [355] 0 0
Carnaxide
Country [356] 0 0
Portugal
State/province [356] 0 0
Coimbra
Country [357] 0 0
Portugal
State/province [357] 0 0
Covilhã
Country [358] 0 0
Portugal
State/province [358] 0 0
Lisboa
Country [359] 0 0
Portugal
State/province [359] 0 0
Porto
Country [360] 0 0
Portugal
State/province [360] 0 0
Setúbal
Country [361] 0 0
Romania
State/province [361] 0 0
Bucharest
Country [362] 0 0
Romania
State/province [362] 0 0
Cluj Napoca
Country [363] 0 0
Russian Federation
State/province [363] 0 0
Moscow
Country [364] 0 0
Russian Federation
State/province [364] 0 0
St. Petersburg
Country [365] 0 0
Singapore
State/province [365] 0 0
Singapore
Country [366] 0 0
Slovakia
State/province [366] 0 0
Banska Bystrica
Country [367] 0 0
Slovakia
State/province [367] 0 0
Bratislava
Country [368] 0 0
Slovakia
State/province [368] 0 0
Kosice
Country [369] 0 0
Slovakia
State/province [369] 0 0
Zilina
Country [370] 0 0
South Africa
State/province [370] 0 0
Bloemfontein
Country [371] 0 0
South Africa
State/province [371] 0 0
Boksburg
Country [372] 0 0
South Africa
State/province [372] 0 0
Cape Town
Country [373] 0 0
South Africa
State/province [373] 0 0
Johannesburg
Country [374] 0 0
South Africa
State/province [374] 0 0
Pretoria
Country [375] 0 0
South Africa
State/province [375] 0 0
Randburg
Country [376] 0 0
South Africa
State/province [376] 0 0
Somerset West
Country [377] 0 0
Spain
State/province [377] 0 0
Barcelona
Country [378] 0 0
Spain
State/province [378] 0 0
Cadiz
Country [379] 0 0
Spain
State/province [379] 0 0
Fuenlabrada (Madrid)
Country [380] 0 0
Spain
State/province [380] 0 0
Leganés, Madrid
Country [381] 0 0
Spain
State/province [381] 0 0
Madrid-San Lorenzo Del Escorial
Country [382] 0 0
Spain
State/province [382] 0 0
Madrid
Country [383] 0 0
Spain
State/province [383] 0 0
Móstoles (Madrid)
Country [384] 0 0
Spain
State/province [384] 0 0
Sabadell
Country [385] 0 0
Sweden
State/province [385] 0 0
Göteboerg
Country [386] 0 0
Sweden
State/province [386] 0 0
Jönköping
Country [387] 0 0
Sweden
State/province [387] 0 0
Linköping
Country [388] 0 0
Sweden
State/province [388] 0 0
Malmö
Country [389] 0 0
Sweden
State/province [389] 0 0
Norrköping
Country [390] 0 0
Sweden
State/province [390] 0 0
Nässjö
Country [391] 0 0
Sweden
State/province [391] 0 0
Stockholm
Country [392] 0 0
Sweden
State/province [392] 0 0
Umeå
Country [393] 0 0
Sweden
State/province [393] 0 0
Uppsala
Country [394] 0 0
Sweden
State/province [394] 0 0
Västerås
Country [395] 0 0
Sweden
State/province [395] 0 0
Örebro
Country [396] 0 0
Switzerland
State/province [396] 0 0
Basel
Country [397] 0 0
Switzerland
State/province [397] 0 0
Bellinzona
Country [398] 0 0
Switzerland
State/province [398] 0 0
Bern
Country [399] 0 0
Switzerland
State/province [399] 0 0
Lugano
Country [400] 0 0
Taiwan
State/province [400] 0 0
Changhua County
Country [401] 0 0
Taiwan
State/province [401] 0 0
Hualien
Country [402] 0 0
Taiwan
State/province [402] 0 0
Kaohsiung
Country [403] 0 0
Taiwan
State/province [403] 0 0
Taichung
Country [404] 0 0
Taiwan
State/province [404] 0 0
Tainan
Country [405] 0 0
Taiwan
State/province [405] 0 0
Taipei
Country [406] 0 0
Taiwan
State/province [406] 0 0
Taoyuan
Country [407] 0 0
Thailand
State/province [407] 0 0
Bangkok
Country [408] 0 0
Thailand
State/province [408] 0 0
Chiangmai
Country [409] 0 0
Thailand
State/province [409] 0 0
Khon Kaen
Country [410] 0 0
Thailand
State/province [410] 0 0
Muang Nakhonratchasima
Country [411] 0 0
Turkey
State/province [411] 0 0
Adana
Country [412] 0 0
Turkey
State/province [412] 0 0
Ankara
Country [413] 0 0
Turkey
State/province [413] 0 0
Izmir
Country [414] 0 0
Ukraine
State/province [414] 0 0
Dnyepropetrovsk
Country [415] 0 0
Ukraine
State/province [415] 0 0
Kharkiv
Country [416] 0 0
Ukraine
State/province [416] 0 0
Kharkov
Country [417] 0 0
Ukraine
State/province [417] 0 0
Kiev
Country [418] 0 0
Ukraine
State/province [418] 0 0
Lvov
Country [419] 0 0
United Kingdom
State/province [419] 0 0
Birmingham
Country [420] 0 0
United Kingdom
State/province [420] 0 0
Chertsey
Country [421] 0 0
United Kingdom
State/province [421] 0 0
Glasgow
Country [422] 0 0
United Kingdom
State/province [422] 0 0
Harrow
Country [423] 0 0
United Kingdom
State/province [423] 0 0
Hull
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Kirkcaldy, Fife
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Londonderry
Country [426] 0 0
United Kingdom
State/province [426] 0 0
London
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Newcastle upon Tyne
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Newport
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Northampton
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Portadown, County Atrim
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Romford, Essex
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Stoke-On-Trent
Country [433] 0 0
United Kingdom
State/province [433] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Uppsala University
Address [2] 0 0
Country [2] 0 0

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00262600