Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

Hyperlipidemia Clinical Trial

Official title:

A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137462
• Other study ID #: A5091019
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: November 15, 2007
• Start date: November 2004
• Est. completion date: September 2006

Study information

• Verified date: December 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Description:

For additional information please call: 1-800-718-1021

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Statin eligible per NCEP ATP-III guidelines

• At least 18 years of age

Exclusion Criteria:

• Women who are pregnant or lactating, or planning to become pregnant

• Intolerance to statin therapy

• 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

Study Design

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• torcetrapib/atorvastatin

• atorvastatin

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Charlottetown	Prince Edward Island
Canada	Pfizer Investigational Site	Coquitlam	British Columbia
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Mirabel	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Pointe-Claire	Quebec
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	St. Georges de Beauce	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Boynton Beach	Florida
United States	Pfizer Investigational Site	Bridgeport	Connecticut
United States	Pfizer Investigational Site	Burlington	Massachusetts
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Doylestown	Pennsylvania
United States	Pfizer Investigational Site	Fairfield	Connecticut
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Gainsville	Florida
United States	Pfizer Investigational Site	Golden	Colorado
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Keizer	Oregon
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Madisonville	Kentucky
United States	Pfizer Investigational Site	McKinney	Texas
United States	Pfizer Investigational Site	Morristown	Tennessee
United States	Pfizer Investigational Site	Mt. Pleasant	South Carolina
United States	Pfizer Investigational Site	Mt. Pleasant	South Carolina
United States	Pfizer Investigational Site	Olathe	Kansas
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Orchard Park	New York
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	Salem	Oregon
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sebastian	Florida
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Trumbull	Connecticut
United States	Pfizer Investigational Site	Union Grove	Alabama
United States	Pfizer Investigational Site	Vero Beach	Florida
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.
Secondary	Changes in levels of lipids and other biomarkers.