|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00240643 |
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 |
Atrial Fibrillation |
Drug: SB424323 |
Phase II |
Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
ChemIDplus related topics: | Acetylsalicylic acid |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 640 |
Study Start Date: | November 2005 |
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
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 118 Study Locations |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 101724 |
First Received: | October 14, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00240643 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
|
|
|