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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267280

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States
United States, California
Pfizer Investigational Site
Alhambra, California, United States
Pfizer Investigational Site
Inglewood, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
United States, Delaware
Pfizer Investigational Site
Wilmington, Delaware, United States
United States, Florida
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Merritt Island, Florida, United States
Pfizer Investigational Site
Pensacola, Florida, United States
Pfizer Investigational Site
Vero Beach, Florida, United States
Pfizer Investigational Site
Winter Park, Florida, United States
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Conyers, Georgia, United States
Pfizer Investigational Site
Woodstock, Georgia, United States
United States, Illinois
Pfizer Investigational Site
Hinsdale, Illinois, United States
Pfizer Investigational Site
La Grange, Illinois, United States
Pfizer Investigational Site
Park Ridge, Illinois, United States
Pfizer Investigational Site
Springfield, Illinois, United States
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Bethesda, Maryland, United States
Pfizer Investigational Site
Elkton, Maryland, United States
United States, Michigan
Pfizer Investigational Site
Flint, Michigan, United States
United States, Missouri
Pfizer Investigational Site
Springfield, Missouri, United States
United States, New Jersey
Pfizer Investigational Site
Lawrenceville, New Jersey, United States
United States, New York
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Seaford, New York, United States
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Mansfield, Ohio, United States
United States, Oregon
Pfizer Investigational Site
Hillsboro, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Beaver, Pennsylvania, United States
Pfizer Investigational Site
Flourtown, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Yardley, Pennsylvania, United States
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States
United States, Tennessee
Pfizer Investigational Site
Collierville, Tennessee, United States
Pfizer Investigational Site
Kingsport, Tennessee, United States
Pfizer Investigational Site
Knoxville, Tennessee, United States
United States, Texas
Pfizer Investigational Site
North Richland Hills, Texas, United States
Pfizer Investigational Site
Spring, Texas, United States
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
West Jordan, Utah, United States
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States
United States, Washington
Pfizer Investigational Site
Bellevue, Washington, United States
Pfizer Investigational Site
Puyallup, Washington, United States
Pfizer Investigational Site
Tacoma, Washington, United States
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:
Hyperlipidemias
Dyslipidemias
Hypercholesterolemia
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Atorvastatin
Torcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014