Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00240643

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 II

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: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

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

Intervention Details:

Other Name: SB424323

Detailed Description:

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

Show 116 Study Locations

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:	November 10, 2011
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 February 09, 2012