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NCT00185146 Clinical Trial

Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

Atherosclerosis Clinical Trial

Official title:
Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185146
Other study ID # SE-505/14
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated March 27, 2007
Start date September 2002
Est. completion date August 2005

Study information
Verified date March 2007
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pactimibe

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Secondary Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
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