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A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00267280
First received: December 19, 2005
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 (A5091031)

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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: NCT00267280

  Show 51 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00267280     History of Changes
Other Study ID Numbers: A5091031
Study First Received: December 19, 2005
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Atorvastatin
Torcetrapib
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013