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

GSK study ID
101724
See study documents
Clinicaltrials.gov ID
NCT00240643
See results summary
EudraCT ID
2005-001256-20
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 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
    Primary completion date:
    2006-28-12
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Mont de Marsan, France, 40000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cadiz, Spain, 11009
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Kissimmee, Florida, United States, 34741
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04177
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cordoba, Córdova, Argentina, 5003
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Hamilton, New Zealand, 2001
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 136 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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
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