Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

March 27, 2007 updated by: Sankyo Pharma Gmbh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of pactimibe versus placebo on the progression of atherosclerosis

Secondary Outcome Measures

Outcome Measure
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sankyo Pharma Gmbh

Investigators

  • Principal Investigator: P U Witte, MD, PhD, FFPM, IMFORM GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

March 28, 2007

Last Update Submitted That Met QC Criteria

March 27, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE-505/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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