Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pactimibe

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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P U Witte, MD, PhD, FFPM

Role: PRINCIPAL_INVESTIGATOR

IMFORM GmbH

Locations

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Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SE-505/14

Identifier Type: -

Identifier Source: org_study_id