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

Purpose

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

Condition	Intervention	Phase
Coronary Disease Coronary Arteriosclerosis Hyperlipidemia	Drug: torcetrapib/atorvastatin Drug: atorvastatin	Phase III

MedlinePlus related topics:

Heart Diseases Ultrasound

ChemIDplus related topics:

Atorvastatin Atorvastatin calcium Torcetrapib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Outcome Measures:

Changes in levels of lipids and other biomarkers.

Estimated Enrollment:	1100
Study Start Date:	October 2003
Study Completion Date:	September 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134173

Show 148 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Nissen SE, Tardif JC, Nicholls SJ, Revkin JH, Shear CL, Duggan WT, Ruzyllo W, Bachinsky WB, Lasala GP, Tuzcu EM; ILLUSTRATE Investigators. Effect of torcetrapib on the progression of coronary atherosclerosis. N Engl J Med. 2007 Mar 29;356(13):1304-16. Epub 2007 Mar 26.

Study ID Numbers:	A5091005
First Received:	August 22, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00134173
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases

Heart Diseases

Hyperlipidemias

Metabolic Diseases

Myocardial Ischemia

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Disease

Torcetrapib

Metabolic disorder

Atorvastatin

Coronary Artery Disease

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00134173