A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.

This study has been completed.

First Received: December 19, 2005 Last Updated: November 20, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00267254

Purpose

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

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Condition	Intervention	Phase
Hyperlipidemia Dyslipidemia Hypercholesterolemia	Drug: torcetrapib/atorvastatin Drug: simvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Torcetrapib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091030)

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.

Secondary Outcome Measures:

Changes in other lipid parameters and other biomarkers.

Estimated Enrollment:	640
Study Start Date:	January 2006
Study Completion Date:	August 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

Women who are pregnant or lactating, or planning to become pregnant.
Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
Subjects with significant liver or kidney disease or significant heart failure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267254

Show 50 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional 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

No publications provided

Study ID Numbers:	A5091030
Study First Received:	December 19, 2005
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00267254 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Torcetrapib
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Torcetrapib
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009