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/NCT00045760




Registration number
NCT00045760
Ethics application status
Date submitted
9/09/2002
Date registered
10/09/2002
Date last updated
20/07/2006

Titles & IDs
Public title
The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis
Scientific title
Secondary ID [1] 0 0
F1K-MC-EVCL
Secondary ID [2] 0 0
7252, 6669
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Adult patients with severe sepsis.
* Presence of a suspected or proven infection.
* One or more sepsis-associated organ failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country.
* Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
* Platelet count <30,000/mm3.
* Are receiving therapeutic heparin.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Other design features
Phase
Phase 4
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
1/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Garran
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Camperdown
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Kingswood
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Liverpool
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Randwick
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - St. Leonards
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Tiwi
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Douglas
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Herston
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Adelaide
Recruitment hospital [11] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Bedford Park
Recruitment hospital [12] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Hobart
Recruitment hospital [13] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Box Hill
Recruitment hospital [14] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Dandenong
Recruitment hospital [15] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Fitzroy
Recruitment hospital [16] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Footscray
Recruitment hospital [17] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Heidelberg
Recruitment hospital [18] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Parkville
Recruitment hospital [19] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Prahran
Recruitment hospital [20] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Nedlands
Recruitment hospital [21] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
- Liverpool
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
- St. Leonards
Recruitment postcode(s) [7] 0 0
- Tiwi
Recruitment postcode(s) [8] 0 0
- Douglas
Recruitment postcode(s) [9] 0 0
- Herston
Recruitment postcode(s) [10] 0 0
- Adelaide
Recruitment postcode(s) [11] 0 0
- Bedford Park
Recruitment postcode(s) [12] 0 0
- Hobart
Recruitment postcode(s) [13] 0 0
- Box Hill
Recruitment postcode(s) [14] 0 0
- Dandenong
Recruitment postcode(s) [15] 0 0
- Fitzroy
Recruitment postcode(s) [16] 0 0
- Footscray
Recruitment postcode(s) [17] 0 0
- Heidelberg
Recruitment postcode(s) [18] 0 0
- Parkville
Recruitment postcode(s) [19] 0 0
- Prahran
Recruitment postcode(s) [20] 0 0
- Nedlands
Recruitment postcode(s) [21] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maine
Country [19] 0 0
United States of America
State/province [19] 0 0
Maryland
Country [20] 0 0
United States of America
State/province [20] 0 0
Massachusetts
Country [21] 0 0
United States of America
State/province [21] 0 0
Michigan
Country [22] 0 0
United States of America
State/province [22] 0 0
Minnesota
Country [23] 0 0
United States of America
State/province [23] 0 0
Mississippi
Country [24] 0 0
United States of America
State/province [24] 0 0
Missouri
Country [25] 0 0
United States of America
State/province [25] 0 0
Montana
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
New Jersey
Country [28] 0 0
United States of America
State/province [28] 0 0
New Mexico
Country [29] 0 0
United States of America
State/province [29] 0 0
New York
Country [30] 0 0
United States of America
State/province [30] 0 0
North Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
North Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Ohio
Country [33] 0 0
United States of America
State/province [33] 0 0
Oklahoma
Country [34] 0 0
United States of America
State/province [34] 0 0
Pennsylvania
Country [35] 0 0
United States of America
State/province [35] 0 0
South Carolina
Country [36] 0 0
United States of America
State/province [36] 0 0
South Dakota
Country [37] 0 0
United States of America
State/province [37] 0 0
Tennessee
Country [38] 0 0
United States of America
State/province [38] 0 0
Texas
Country [39] 0 0
United States of America
State/province [39] 0 0
Utah
Country [40] 0 0
United States of America
State/province [40] 0 0
Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Washington
Country [42] 0 0
United States of America
State/province [42] 0 0
West Virginia
Country [43] 0 0
United States of America
State/province [43] 0 0
Wisconsin
Country [44] 0 0
Austria
State/province [44] 0 0
Innsbruck
Country [45] 0 0
Austria
State/province [45] 0 0
Wien
Country [46] 0 0
Belgium
State/province [46] 0 0
Brussells
Country [47] 0 0
Belgium
State/province [47] 0 0
Bruxelles
Country [48] 0 0
Belgium
State/province [48] 0 0
Gent
Country [49] 0 0
Belgium
State/province [49] 0 0
Liege
Country [50] 0 0
Belgium
State/province [50] 0 0
Mons
Country [51] 0 0
Belgium
State/province [51] 0 0
Ottignies
Country [52] 0 0
Belgium
State/province [52] 0 0
Yvior
Country [53] 0 0
Brazil
State/province [53] 0 0
BA
Country [54] 0 0
Brazil
State/province [54] 0 0
PR
Country [55] 0 0
Brazil
State/province [55] 0 0
SC
Country [56] 0 0
Brazil
State/province [56] 0 0
Porto Alegre
Country [57] 0 0
Brazil
State/province [57] 0 0
Rio De Janeiro
Country [58] 0 0
Brazil
State/province [58] 0 0
Rio de Janeiro
Country [59] 0 0
Brazil
State/province [59] 0 0
Sao Paulo
Country [60] 0 0
Canada
State/province [60] 0 0
Alberta
Country [61] 0 0
Canada
State/province [61] 0 0
British Columbia
Country [62] 0 0
Canada
State/province [62] 0 0
Manitoba
Country [63] 0 0
Canada
State/province [63] 0 0
New Brunswick
Country [64] 0 0
Canada
State/province [64] 0 0
Nova Scotia
Country [65] 0 0
Canada
State/province [65] 0 0
Ontario
Country [66] 0 0
Canada
State/province [66] 0 0
Quebec
Country [67] 0 0
Canada
State/province [67] 0 0
Saskatchewan
Country [68] 0 0
Chile
State/province [68] 0 0
Santiago
Country [69] 0 0
Czech Republic
State/province [69] 0 0
Brno
Country [70] 0 0
Czech Republic
State/province [70] 0 0
Hradec Kralove
Country [71] 0 0
Czech Republic
State/province [71] 0 0
Olomouc
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Ostrava Poruba
Country [73] 0 0
Czech Republic
State/province [73] 0 0
Plzen
Country [74] 0 0
Czech Republic
State/province [74] 0 0
Praha 10
Country [75] 0 0
Czech Republic
State/province [75] 0 0
Praha 2
Country [76] 0 0
Czech Republic
State/province [76] 0 0
Praha 5 Motol
Country [77] 0 0
Czech Republic
State/province [77] 0 0
Praha 8
Country [78] 0 0
Denmark
State/province [78] 0 0
Esbjerg
Country [79] 0 0
Denmark
State/province [79] 0 0
Hvidovre
Country [80] 0 0
Denmark
State/province [80] 0 0
Roskilde
Country [81] 0 0
Denmark
State/province [81] 0 0
Viborg
Country [82] 0 0
Egypt
State/province [82] 0 0
Alexandria
Country [83] 0 0
Egypt
State/province [83] 0 0
Cairo
Country [84] 0 0
Finland
State/province [84] 0 0
Helsinki, Hus
Country [85] 0 0
Finland
State/province [85] 0 0
Jyvaskyla
Country [86] 0 0
Finland
State/province [86] 0 0
Kuopio
Country [87] 0 0
Finland
State/province [87] 0 0
Oulu
Country [88] 0 0
Finland
State/province [88] 0 0
Tampere
Country [89] 0 0
Finland
State/province [89] 0 0
Turku
Country [90] 0 0
France
State/province [90] 0 0
Argenteuil
Country [91] 0 0
France
State/province [91] 0 0
Aulnay-Sous-Bois
Country [92] 0 0
France
State/province [92] 0 0
Besancon Cedex
Country [93] 0 0
France
State/province [93] 0 0
Bondy Cedex
Country [94] 0 0
France
State/province [94] 0 0
Clichy
Country [95] 0 0
France
State/province [95] 0 0
Corbeil Essonnes Cedex
Country [96] 0 0
France
State/province [96] 0 0
Dijon Cedex
Country [97] 0 0
France
State/province [97] 0 0
Garches
Country [98] 0 0
France
State/province [98] 0 0
Gleize
Country [99] 0 0
France
State/province [99] 0 0
Le Chesnay Cedex
Country [100] 0 0
France
State/province [100] 0 0
Le Kremlin Bicetre Cedex
Country [101] 0 0
France
State/province [101] 0 0
Lille Cedex
Country [102] 0 0
France
State/province [102] 0 0
Lille
Country [103] 0 0
France
State/province [103] 0 0
Limoges Cedex
Country [104] 0 0
France
State/province [104] 0 0
Longsumeau Cedex
Country [105] 0 0
France
State/province [105] 0 0
Lyon Cedex 03
Country [106] 0 0
France
State/province [106] 0 0
Marseille Cedex 09
Country [107] 0 0
France
State/province [107] 0 0
Nancy
Country [108] 0 0
France
State/province [108] 0 0
Nice Cedex 1
Country [109] 0 0
France
State/province [109] 0 0
Nice Cedex 3
Country [110] 0 0
France
State/province [110] 0 0
Nimes
Country [111] 0 0
France
State/province [111] 0 0
Orleans Cedex 2
Country [112] 0 0
France
State/province [112] 0 0
Paris Cedex 10
Country [113] 0 0
France
State/province [113] 0 0
Paris Cedex 13
Country [114] 0 0
France
State/province [114] 0 0
Paris Cedex 14
Country [115] 0 0
France
State/province [115] 0 0
Poissy
Country [116] 0 0
France
State/province [116] 0 0
Poitiers
Country [117] 0 0
France
State/province [117] 0 0
Pontoise Cedex
Country [118] 0 0
France
State/province [118] 0 0
Rennes Cedex 9
Country [119] 0 0
France
State/province [119] 0 0
Saint Denis Cedex 1
Country [120] 0 0
France
State/province [120] 0 0
Saint Etienne Cedex 2
Country [121] 0 0
France
State/province [121] 0 0
Strasbourg Cedex
Country [122] 0 0
France
State/province [122] 0 0
Toulouse
Country [123] 0 0
France
State/province [123] 0 0
Tours Cedex
Country [124] 0 0
France
State/province [124] 0 0
Vesoul
Country [125] 0 0
Germany
State/province [125] 0 0
Aachen
Country [126] 0 0
Germany
State/province [126] 0 0
Berlin
Country [127] 0 0
Germany
State/province [127] 0 0
Bonn
Country [128] 0 0
Germany
State/province [128] 0 0
Bremen
Country [129] 0 0
Germany
State/province [129] 0 0
Erfurt
Country [130] 0 0
Germany
State/province [130] 0 0
Essen
Country [131] 0 0
Germany
State/province [131] 0 0
Freiburg
Country [132] 0 0
Germany
State/province [132] 0 0
Gottingen
Country [133] 0 0
Germany
State/province [133] 0 0
Halle
Country [134] 0 0
Germany
State/province [134] 0 0
Hamburg
Country [135] 0 0
Germany
State/province [135] 0 0
Hannover
Country [136] 0 0
Germany
State/province [136] 0 0
Leipzig
Country [137] 0 0
Germany
State/province [137] 0 0
Lubeck
Country [138] 0 0
Germany
State/province [138] 0 0
Mannheim
Country [139] 0 0
Germany
State/province [139] 0 0
Munchen
Country [140] 0 0
Germany
State/province [140] 0 0
Regensburg
Country [141] 0 0
Germany
State/province [141] 0 0
Reutlingen
Country [142] 0 0
Germany
State/province [142] 0 0
Tubingen
Country [143] 0 0
India
State/province [143] 0 0
Andhara Pradesh
Country [144] 0 0
India
State/province [144] 0 0
Delhi
Country [145] 0 0
India
State/province [145] 0 0
Karnataka
Country [146] 0 0
India
State/province [146] 0 0
Maharashtra
Country [147] 0 0
India
State/province [147] 0 0
UP
Country [148] 0 0
India
State/province [148] 0 0
Hyderabad
Country [149] 0 0
Italy
State/province [149] 0 0
Bari
Country [150] 0 0
Italy
State/province [150] 0 0
CT
Country [151] 0 0
Italy
State/province [151] 0 0
Milano
Country [152] 0 0
Italy
State/province [152] 0 0
MI
Country [153] 0 0
Italy
State/province [153] 0 0
PD
Country [154] 0 0
Italy
State/province [154] 0 0
Savona
Country [155] 0 0
Italy
State/province [155] 0 0
Vicenza
Country [156] 0 0
Italy
State/province [156] 0 0
Ancona
Country [157] 0 0
Italy
State/province [157] 0 0
Arezzo
Country [158] 0 0
Italy
State/province [158] 0 0
Bergamo
Country [159] 0 0
Italy
State/province [159] 0 0
Bologna
Country [160] 0 0
Italy
State/province [160] 0 0
Bolzano
Country [161] 0 0
Italy
State/province [161] 0 0
Cagliari
Country [162] 0 0
Italy
State/province [162] 0 0
Como
Country [163] 0 0
Italy
State/province [163] 0 0
Ferrara
Country [164] 0 0
Italy
State/province [164] 0 0
Genova
Country [165] 0 0
Italy
State/province [165] 0 0
Lecce
Country [166] 0 0
Italy
State/province [166] 0 0
Lecco
Country [167] 0 0
Italy
State/province [167] 0 0
Padova
Country [168] 0 0
Italy
State/province [168] 0 0
Palermo
Country [169] 0 0
Italy
State/province [169] 0 0
Pavia
Country [170] 0 0
Italy
State/province [170] 0 0
Pesaro
Country [171] 0 0
Italy
State/province [171] 0 0
Pisa
Country [172] 0 0
Italy
State/province [172] 0 0
Roma
Country [173] 0 0
Italy
State/province [173] 0 0
Sassari
Country [174] 0 0
Italy
State/province [174] 0 0
Siena
Country [175] 0 0
Italy
State/province [175] 0 0
Treviglio
Country [176] 0 0
Italy
State/province [176] 0 0
Trieste
Country [177] 0 0
Italy
State/province [177] 0 0
Varese
Country [178] 0 0
Lebanon
State/province [178] 0 0
Beirut
Country [179] 0 0
Mexico
State/province [179] 0 0
DF
Country [180] 0 0
Mexico
State/province [180] 0 0
Nuevo Leon
Country [181] 0 0
Mexico
State/province [181] 0 0
Mexico City
Country [182] 0 0
Netherlands
State/province [182] 0 0
Apeldoorn
Country [183] 0 0
Netherlands
State/province [183] 0 0
Breda
Country [184] 0 0
Netherlands
State/province [184] 0 0
Den Bosch
Country [185] 0 0
Netherlands
State/province [185] 0 0
Tilburg
Country [186] 0 0
New Zealand
State/province [186] 0 0
Canterbury
Country [187] 0 0
New Zealand
State/province [187] 0 0
Auckland
Country [188] 0 0
New Zealand
State/province [188] 0 0
Hamilton
Country [189] 0 0
New Zealand
State/province [189] 0 0
Hastings
Country [190] 0 0
Norway
State/province [190] 0 0
Alesund
Country [191] 0 0
Norway
State/province [191] 0 0
Drammen
Country [192] 0 0
Norway
State/province [192] 0 0
Nordbyhagen
Country [193] 0 0
Norway
State/province [193] 0 0
Oslo
Country [194] 0 0
Norway
State/province [194] 0 0
Trondheim
Country [195] 0 0
Romania
State/province [195] 0 0
Sector 2
Country [196] 0 0
Romania
State/province [196] 0 0
Bucharest
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Russia
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Smolensk
Country [199] 0 0
Saudi Arabia
State/province [199] 0 0
Jeddah
Country [200] 0 0
Saudi Arabia
State/province [200] 0 0
Riyadh
Country [201] 0 0
Singapore
State/province [201] 0 0
Singapore
Country [202] 0 0
Slovakia
State/province [202] 0 0
Bratislava
Country [203] 0 0
Slovakia
State/province [203] 0 0
Kosice
Country [204] 0 0
South Africa
State/province [204] 0 0
Cape Province
Country [205] 0 0
South Africa
State/province [205] 0 0
Northern Cape
Country [206] 0 0
South Africa
State/province [206] 0 0
Bloemfontein
Country [207] 0 0
South Africa
State/province [207] 0 0
Cape Town
Country [208] 0 0
South Africa
State/province [208] 0 0
Medunsa
Country [209] 0 0
South Africa
State/province [209] 0 0
Pretoria
Country [210] 0 0
South Africa
State/province [210] 0 0
Thaba Tshwane
Country [211] 0 0
Spain
State/province [211] 0 0
Alicante
Country [212] 0 0
Spain
State/province [212] 0 0
Barcelona
Country [213] 0 0
Spain
State/province [213] 0 0
Cadiz
Country [214] 0 0
Spain
State/province [214] 0 0
Cantabria
Country [215] 0 0
Spain
State/province [215] 0 0
Gran Canaria
Country [216] 0 0
Spain
State/province [216] 0 0
La Coruna
Country [217] 0 0
Spain
State/province [217] 0 0
Madrid
Country [218] 0 0
Spain
State/province [218] 0 0
Vizcaya
Country [219] 0 0
Spain
State/province [219] 0 0
Badajoz
Country [220] 0 0
Spain
State/province [220] 0 0
Burgos
Country [221] 0 0
Spain
State/province [221] 0 0
Castellon
Country [222] 0 0
Spain
State/province [222] 0 0
Murcia
Country [223] 0 0
Spain
State/province [223] 0 0
Palencia
Country [224] 0 0
Spain
State/province [224] 0 0
Palma De Mallorca
Country [225] 0 0
Spain
State/province [225] 0 0
Salmanca
Country [226] 0 0
Spain
State/province [226] 0 0
Santa Cruz De Tenerife
Country [227] 0 0
Spain
State/province [227] 0 0
Sevilla
Country [228] 0 0
Spain
State/province [228] 0 0
Terrassa
Country [229] 0 0
Spain
State/province [229] 0 0
Valencia
Country [230] 0 0
Spain
State/province [230] 0 0
Valladolid
Country [231] 0 0
Sweden
State/province [231] 0 0
Falun
Country [232] 0 0
Sweden
State/province [232] 0 0
Goteborg
Country [233] 0 0
Sweden
State/province [233] 0 0
Huddinge
Country [234] 0 0
Sweden
State/province [234] 0 0
Karistad
Country [235] 0 0
Sweden
State/province [235] 0 0
Kristianstad
Country [236] 0 0
Sweden
State/province [236] 0 0
Ostersund
Country [237] 0 0
Sweden
State/province [237] 0 0
Skovde
Country [238] 0 0
Sweden
State/province [238] 0 0
Stockholm
Country [239] 0 0
Sweden
State/province [239] 0 0
Sundsvall
Country [240] 0 0
Switzerland
State/province [240] 0 0
Bern
Country [241] 0 0
Switzerland
State/province [241] 0 0
Geneve
Country [242] 0 0
Switzerland
State/province [242] 0 0
Zuerich
Country [243] 0 0
Taiwan
State/province [243] 0 0
R. O. C.
Country [244] 0 0
Taiwan
State/province [244] 0 0
Taipei
Country [245] 0 0
Thailand
State/province [245] 0 0
Bangkok
Country [246] 0 0
Thailand
State/province [246] 0 0
Khon Kaen
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Cambridgeshire
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Devon
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Glasgow
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Hampshire
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Hants
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Kent
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Lancashire
Country [254] 0 0
United Kingdom
State/province [254] 0 0
Leicestershire
Country [255] 0 0
United Kingdom
State/province [255] 0 0
London Road
Country [256] 0 0
United Kingdom
State/province [256] 0 0
London
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Manchester
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Middlesex
Country [259] 0 0
United Kingdom
State/province [259] 0 0
Norfolk
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Nottinghamshire
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Scotland
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Surrey
Country [263] 0 0
United Kingdom
State/province [263] 0 0
West Lothian
Country [264] 0 0
United Kingdom
State/province [264] 0 0
West Midlands
Country [265] 0 0
United Kingdom
State/province [265] 0 0
West Yorkshire
Country [266] 0 0
United Kingdom
State/province [266] 0 0
Bradford
Country [267] 0 0
United Kingdom
State/province [267] 0 0
Cardiff
Country [268] 0 0
United Kingdom
State/province [268] 0 0
Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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 not provided in https://clinicaltrials.gov/study/NCT00045760