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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00134485
First received: August 22, 2005
Last updated: October 28, 2007
Last verified: December 2006
History of Changes
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Atorvastatin
 Torcetrapib
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013