Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone. (RADIANCE 1)

April 21, 2015 updated by: Pfizer

Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For additional information please call: 1-800-718-1021

Study Type

Interventional

Enrollment

800

Phase

  • Phase 3

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

  • Canada
      • Quebec, Canada
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Pfizer Investigational Site
    • Quebec
      • Chicoutimi, Quebec, Canada
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada
        • Pfizer Investigational Site
  • Czech Republic
      • Prague, Czech Republic
        • Pfizer Investigational Site
      • Prague 4, Czech Republic
        • Pfizer Investigational Site
  • Finland
      • Kuopio, Finland
        • Pfizer Investigational Site
      • OYS, Finland
        • Pfizer Investigational Site
  • France
      • PARIS Cedex, France
        • Pfizer Investigational Site
      • Toul Cedex, France
        • Pfizer Investigational Site
  • Italy
      • Brescia, Italy
        • Pfizer Investigational Site
      • Pavia, Italy
        • Pfizer Investigational Site
  • Netherlands
      • Alkmaar, Netherlands
        • Pfizer Investigational Site
      • Amsterdam, Netherlands
        • Pfizer Investigational Site
      • Delft, Netherlands
        • Pfizer Investigational Site
      • Goes, Netherlands
        • Pfizer Investigational Site
      • Groningen, Netherlands
        • Pfizer Investigational Site
      • Hoorn, Netherlands
        • Pfizer Investigational Site
      • Leiden, Netherlands
        • Pfizer Investigational Site
      • Nijmegen, Netherlands
        • Pfizer Investigational Site
      • Rotterdam, Netherlands
        • Pfizer Investigational Site
      • Sliedrecht, Netherlands
        • Pfizer Investigational Site
      • Utrecht, Netherlands
        • Pfizer Investigational Site
      • Waalwijk, Netherlands
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa
        • Pfizer Investigational Site
    • Cape Town
      • Parow, Cape Town, South Africa
        • Pfizer Investigational Site
    • Johannesburg
      • Parktown, Johannesburg, South Africa
        • Pfizer Investigational Site
  • United States
    • Connecticut
      • Hartford, Connecticut, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States
        • Pfizer Investigational Site

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Heterozygous Familial Hypercholesterolemia
  • At least 18 years of age

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses)
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
  • Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study

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
Change in intima media thickness as measures by carotid ultrasound

Secondary Outcome Measures

Outcome Measure
Changes in levels of lipids and other biomarkers.

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

December 1, 2003

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5091003

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.

Clinical Trials on Hyperlipidemia

Clinical Trials on atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe