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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00267254
First received: December 19, 2005
Last updated: November 20, 2007
Last verified: April 2007
  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 (A5091030)

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: 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

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tempe, Arizona, United States
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Santa Rosa, California, United States
United States, Florida
Pfizer Investigational Site
Boynton Beach, Florida, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
Merritt Island, Florida, United States
Pfizer Investigational Site
Palm Bay, Florida, United States
Pfizer Investigational Site
Safety Harbor, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States
United States, Kansas
Pfizer Investigational Site
Newton, Kansas, United States
Pfizer Investigational Site
Topeka, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Canton, Michigan, United States
Pfizer Investigational Site
Portage, Michigan, United States
Pfizer Investigational Site
Troy, Michigan, United States
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
St. Louis, Missouri, United States
United States, Montana
Pfizer Investigational Site
Butte, Montana, United States
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States
United States, New Hampshire
Pfizer Investigational Site
Concord, New Hampshire, United States
United States, New Jersey
Pfizer Investigational Site
Trenton, New Jersey, United States
United States, New York
Pfizer Investigational Site
Cooperstown, New York, United States
Pfizer Investigational Site
East Syracuse, New York, United States
Pfizer Investigational Site
Rochester, 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
United States, South Carolina
Pfizer Investigational Site
Clinton, South Carolina, United States
United States, Tennessee
Pfizer Investigational Site
Cordova, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Milan, Tennessee, United States
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Fort Worth, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
United States, Utah
Pfizer Investigational Site
Payson, Utah, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00267254     History of Changes
Other Study ID Numbers: A5091030
Study First Received: December 19, 2005
Last Updated: November 20, 2007
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 April 17, 2014