Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240643
First received: October 14, 2005
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibrillation, Atrial Atrial Fibrillation |
Drug: SB424323 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | See Detailed Description |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Drug Information available for:
Aspirin
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Relationship between anti IIa (a biomarker)and the dose of SB424323.
Secondary Outcome Measures:
- Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.
| Estimated Enrollment: | 640 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: SB424323
Other Name: SB424323
A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with non valvular atrial fibrillation and any of the following:
- </= 60 years old with no heart disease.
- 60 years old with heart disease but no risk factors.
- >/=60 years old and </=75 years old with no risk factors and no heart disease.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240643
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| United States, Alabama | |
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| Mobile, Alabama, United States, 36608 | |
| United States, Michigan | |
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| Troy, Michigan, United States, 48098 | |
| United States, Ohio | |
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| Akron, Ohio, United States, 44313 | |
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00240643 History of Changes |
| Other Study ID Numbers: | 101724 |
| Study First Received: | October 14, 2005 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
non valvular atrial fibrillation stroke aspirin |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013