Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia - Full Text View

Purpose

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

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

Condition	Intervention	Phase
Hypercholesterolemia, Familial Hyperlipidemia	Drug: torcetrapib/atorvastatin Drug: atorvastatin	Phase III

Genetics Home Reference related topics:

cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics:

Cholesterol

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, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in HDL-C and LDL-C

Secondary Outcome Measures:

Changes in other lipid parameters

Estimated Enrollment:	400
Study Start Date:	March 2005
Estimated Study Completion Date:	March 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:

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 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: NCT00134485

Show 41 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Study ID Numbers:	A5091026
First Received:	August 22, 2005
Last Updated:	October 28, 2007
ClinicalTrials.gov Identifier:	NCT00134485
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors

Hypercholesterolemia, autosomal dominant

Hyperlipidemias

Metabolic Diseases

Hyperlipoproteinemia Type II

Metabolism, Inborn Errors

Genetic Diseases, Inborn

Torcetrapib

Metabolic disorder

Hypercholesterolemia

Hyperlipoproteinemias

Dyslipidemias

Atorvastatin

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

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:	NCT00134485