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NCT00134498 Clinical Trial

A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

Hypertriglyceridemia Clinical Trial

Official title:
Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00134498
Other study ID # A5091025
Secondary ID
Status Completed
Phase Phase 3
First received August 22, 2005
Last updated November 15, 2007
Start date February 2005
Est. completion date November 2006

Study information
Verified date March 2007
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 assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of Fredrickson Type IV Hypertriglyceridemia

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

- 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

Intervention

Drug:
• torcetrapib/atorvastatin

• atorvastatin

Locations
Country Name City State
Canada Pfizer Investigational Site Chicoutimi Quebec
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Ste-Foy Quebec
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Baton Rouge Louisiana
United States Pfizer Investigational Site Bethesda Maryland
United States Pfizer Investigational Site Canton Michigan
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Huntington Beach California
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jefferson City Missouri
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Longwood Florida
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Olive Branch Mississippi
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Orangevale California
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Pacific Palisades California
United States Pfizer Investigational Site Portage Michigan
United States Pfizer Investigational Site Richland Michigan
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Scarborough Maine
United States Pfizer Investigational Site Sellersville Pennsylvania
United States Pfizer Investigational Site St. Cloud Minnesota
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Statesville North Carolina
United States Pfizer Investigational Site Studio City California
United States Pfizer Investigational Site Syracuse New York
United States Pfizer Investigational Site Tripler AMC Hawaii
United States Pfizer Investigational Site Tustin California
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Warwick Rhode Island
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site West Seneca 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 HDL-C and non-HDL-C levels
Secondary Changes in levels of other lipid and biomarkers.
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