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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00240643
• Date of registration: 14/10/2005
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
• Scientific 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
• Date of first enrolment: November 2005
• Target sample size: 640
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00240643
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double.
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, Norway, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fibrillation, Atrial

Atrial Fibrillation

Intervention(s)

Drug: SB424323

Primary Outcome(s)

Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary Outcome(s)

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.

Secondary ID(s)

101724

Source(s) of Monetary Support

Please refer to primary and secondary sponsors