A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

December 6, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change coronary artery atheroma volume as measured by intravascular ultrasound.

Original Primary Outcome Measures ^ICMJE

Change coronary artery atheroma volume as measured by intravascular ultrasound.

Change History

Complete list of historical versions of study NCT00134173 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in levels of lipids and other biomarkers.

Original Secondary Outcome Measures ^ICMJE

Changes in levels of lipids and other biomarkers.

Descriptive Information

Brief Title ^ICMJE

A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease

Official Title ^ICMJE

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular 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 Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.

Brief Summary

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

To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

Detailed Description

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Disease
Coronary Arteriosclerosis
Hyperlipidemia

Intervention ^ICMJE

Drug: torcetrapib/atorvastatin
Drug: atorvastatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1100

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

angiographic evidence of coronary atherosclerosis

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.
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 evaluation of response, or render unlikely that the subject would complete the study.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Netherlands, Poland, Spain

Administrative Information

NCT ID ^ICMJE

NCT00134173

Responsible Party

Study ID Numbers ^ICMJE

A5091005

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP