Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

Sankyo Pharma Gmbh200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Atherosclerosis

Interventions

PactimibeDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Unnamed facility

Munich, Germany

Outcomes

Primary Outcomes

Efficacy of pactimibe versus placebo on the progression of atherosclerosis

Secondary Outcomes

Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

Data from ClinicalTrials.gov

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