Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

Phase 2

Completed

• Conditions: Atherosclerosis

• Registration Number: NCT00185146
• Lead Sponsor: Sankyo Pharma Gmbh

Brief Summary

The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-27
• Last Update Posted: 2007-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy)
• Intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography
• Negative pregnancy test for females

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Exclusion Criteria

• Whole blood donation (greater than or equal to 450 ml) during the last three months before study start
• Unstable angina, congestive heart failure or uncontrolled hypertension
• Renal disease including nephrectomy and/or renal transplant
• Hepatic disease or abnormal liver function parameters
• Drug abuse or alcohol addiction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of pactimibe versus placebo on the progression of atherosclerosis

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis