Last updated: 11/04/2018 08:27:58

Odiparcil For The Prevention Of Venous Thromboembolism

GSK study ID
ITI101711
Clinicaltrials.gov ID
NCT00244725
See results summary
EudraCT ID
2004-000610-39
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Dose Ranging Trial for the Evaluation of the Safety, Tolerability and Efficacy of Odiparcil in the Prevention of Venous Thromboembolism following Total Knee Replacement Surgery
Trial description: Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Percentage of participants with total VTE event over 10 ± 2 days of treatment

Timeframe: Up to Visit 7 (10 ± 2 days of treatment)

Secondary outcomes:

Percentage of participants with proximal DVT over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with distal DVT over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with PE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Number of death due to VTE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with total asymptomatic VTE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of total symptomatic VTE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up

Timeframe: Up to 68 days

Percentage of participants with major bleeds over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with total VTE any time after start of treatment

Timeframe: Up to Visit 9 (Day 28 post treatment)

Percentage of participants with elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin (DB) and total bilirubin (TB) by 2 fold and 3 fold from upper normal limits (ULN) any time on-treatment

Timeframe: Up to 12 days

Interventions:
  • Drug: Odiparcil
  • Drug: Warfarin
  • Drug: Coumadin
    • Enrollment:
    961
    Primary completion date:
    2006-15-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Deep Vein Thrombosis, Fibrillation, Atrial, Pulmonary Embolism
    Product
    odiparcil
    Collaborators
    Not applicable
    Study date(s)
    September 2005 to September 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    35 years - 0 Not applicable
    Accepts healthy volunteers
    No
    • Women must be unable to have children.
    • Will have a total knee replacement.
    • Allergic to any X-ray dye.
    • Allergies or reactions to warfarin or coumadin.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Women must be unable to have children.
    • Will have a total knee replacement.
    Exclusion criteria:
    • Allergic to any X-ray dye.
    • Allergies or reactions to warfarin or coumadin.
    • Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
    • On anticoagulation therapy.
    • Renal impairment.
    • Participated in any clinical trial in the past 30 days.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lubbock, Texas, United States, 79410
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ajax, Ontario, Canada, L1S 2J5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarsota, Florida, United States, 34239
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Secunderabad, India, 500 003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23249
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vilnius, Lithuania, LT-04128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78217
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North York, Ontario, Canada, M3M 2G2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90509
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45242
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Riga, Latvia, LV1004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19140
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75246
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mineola, New York, United States, 11501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Don Mills, Ontario, Canada, M3C 1W3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vinnitsa, Ukraine, 21032
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Fife, United Kingdom, KY2 5AH
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H1T 2M4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43614
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dnepropetrovsk, Ukraine, 49005
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Deland, Florida, United States, 32720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Irkutsk, Russia, 664003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chennai, India, 600 040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oshawa, Ontario, Canada, L1G 2B9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lonetree, Colorado, United States, 80124
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Southport, Queensland, Australia, 4215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wroclaw, Poland, 50-043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wigan, United Kingdom, WN6 9EP
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21215-5271
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Scarborough, Ontario, Canada, M1W 3W3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sainte Jerome, Québec, Canada, J7Z 5T3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Box Hill, Victoria, Australia, 3128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Banning, California, United States, 92220
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, West Midlands, United Kingdom, B18 7QH
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Klaipeda, Lithuania, LT-92288
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kfar Saba, Israel, 44281
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mosocow, Russia, 115516
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kurgan, Russia, 640014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waterloo, Ontario, Canada, N2J 1C4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kaunas, Lithuania, LT-50009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Krakow, Poland, 31-862
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tel-Aviv, Israel, 64239
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riga, Latvia, LV1005
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95817
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Allentown, Pennsylvania, United States, 18103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27704
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Altoona, Pennsylvania, United States, 16601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Warren, Michigan, United States, 48089
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80907
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Haifa, Israel, 31096
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kyiv, Ukraine, 03103
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Bialystok, Poland, 15-276
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bournmouth, United Kingdom, BH7 7DW
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Yuba City, California, United States, 95991
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cherkasy, Ukraine, 18009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    London, United Kingdom, SE5 9JP
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Camperdown, New South Wales, Australia, 2050
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pretoria, South Africa
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Centurion, South Africa, 157
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newmarket, Ontario, Canada, L3Y 2P9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R3J 3M7
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Geelong, Victoria, Australia, 3220
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sosnowiec, Poland, 41-200
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Québec, Québec, Canada, G1J 1Z4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rostov- on- Don, Russia, 344718
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kyiv, Ukraine, 04107
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33756
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23507
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32216
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ringwood East, Victoria, Australia, 3135
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Petach Tikva, Israel, 49372
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hershey, Pennsylvania, United States, 17033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Moscow, Russia, 117415
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Windsor, Victoria, Australia, 3181
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mosocow, Russia, 117593
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pretoria, Gauteng, South Africa, 0084
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlottetown, Prince Edward Island, Canada, C1A 1L2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40509
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clayton, Victoria, Australia, 3168
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Camp Hill, Pennsylvania, United States, 17011
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marshfield, Wisconsin, United States, 54449
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23229
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Huntington, West Virginia, United States, 25701
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34239
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21218
    Status
    Study Complete
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    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-15-09
    Actual study completion date
    2006-15-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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