Last updated: 11/02/2018 23:39:33
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250mg, 375mg and 500 mg) administered twice daily for 16 weeks, on top of asprin (325mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke
Trial description: This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Anti IIa activity upto Week 16
Timeframe: Upto Week 16
Secondary outcomes:
Descriptive statistics of SB424323 concentrations at each time point
Timeframe: Upto Week 16
Population pharmacokinetic parameters clearance (CL) and volume of distribution (Vd) of SB424323.
Timeframe: Upto Week 16
Correlations between the pharmacokinetics of SB424323 and relevant safety and efficacy endpoints
Timeframe: Upto Week 16
Percentage of participants with ischemic stroke, transient ischemic attack (TIA) and systemic embolism (SE) over the course of study
Timeframe: Upto Week 20
Percentage of participants with major or clinically relevant bleeding events at any time post randomization (ATPR)
Timeframe: Upto Week 20
Number of participants with elevated liver function tests (LFTs) any time on treatment (ATOT)
Timeframe: Upto Week 20
Number of participants with elevated creatinine phosphokinase (CPK) levels ATOT
Timeframe: Upto Week 20
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Upto Week 20
Change from baseline in Alkaline Phosphatase (AP), ALT, AST, Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) upto Week 20
Timeframe: Upto Week 20
Change from baseline in DB, TB, Creatinine, Uric Acid (UA) upto Week 20
Timeframe: Upto Week 20
Change from baseline in Calcium, Chloride, Carbon Dioxide (CO2) content / Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Phosphorus (Inorganic) upto Week 20
Timeframe: Upto Week 20
Change from baseline in Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Total Protein (TP) upto Week 20
Timeframe: Upto Week 20
Change from baseline in Platelet count (PC), White Blood Cell count (WBCC) upto Week 20
Timeframe: Upto Week 20
Change from baseline in Hematocrit upto Week 20
Timeframe: Upto Week 20
Change from baseline in Mean Corpuscle Hemoglobin (MCH) upto Week 20
Timeframe: Upto Week 20
Change from baseline in Mean Corpuscle Volume (MCV) upto Week 20
Timeframe: Upto Week 20
Change from baseline in Red Blood Cell Count (RBCC) upto Week 20
Timeframe: Upto Week 20
Interventions:
Drug: Placebo
Drug: Odiparcil 250 mg
Drug: Odiparcil 375 mg
Drug: Odiparcil 500 mg
Drug: Aspirin 325 mg
Enrollment:
457
Observational study model:
Not applicable
Primary completion date:
2006-28-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Fibrillation, Atrial
Product
odiparcil
Collaborators
Not applicable
Study date(s)
November 2005 to December 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Patients with non valvular atrial fibrillation and any of the following:
- </= 60 years old with no heart disease.
- Previous heart attack or stroke.
- History of high blood pressure, diabetes or a prior blood clot.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with non valvular atrial fibrillation and any of the following:
- 60 years old with heart disease but no risk factors.
- >/=60 years old and
- Must be able to take aspirin.
Exclusion criteria:
- Previous heart attack or stroke.
- History of high blood pressure, diabetes or a prior blood clot.
- Liver or kidney disease.
- Need for anti-thrombotic or anti-platelet drugs.
- Need for cardiovascular medicines.
Trial location(s)
Location
GSK Investigational Site
Kissimmee, Florida, United States, 34741
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cordoba, Córdova, Argentina, 5003
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moron-Provincia de Buenos Aires, Argentina, 1709
Status
Study Complete
Location
GSK Investigational Site
Koenigsbrueck, Sachsen, Germany, 01936
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, United Kingdom, M23 9LT
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, West Midlands, United Kingdom, B18 7QH
Status
Study Complete
Location
GSK Investigational Site
Einbeck, Niedersachsen, Germany, 37574
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 5R3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G11 6NT
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
Status
Study Complete
Location
GSK Investigational Site
Northeim, Niedersachsen, Germany, 37154
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
Status
Study Complete
Location
GSK Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Weyhe-Leeste, Niedersachsen, Germany, 28844
Status
Study Complete
Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8P 3B6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muehldorf, Bayern, Germany, 84453
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Capital Fefderal, Buenos Aires, Argentina
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1704
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1405
Status
Study Complete
Location
GSK Investigational Site
Città della Pieve (PG), Umbria, Italy, 06062
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 1QL
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wermsdorf, Sachsen, Germany, 04779
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1180AAX
Status
Study Complete
Location
GSK Investigational Site
Auburn, Maine, United States, 04210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1221
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2G8
Status
Study Complete
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22415
Status
Terminated/Withdrawn
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04024-002
Status
Study Complete
Location
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-28-12
Actual study completion date
2006-28-12
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website