Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.

Hyperlipoproteinemia Type III Clinical Trial

Official title:

Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00145431
• Other study ID #: A5091024
• Status: Terminated
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: February 15, 2012
• Start date: March 2005
• Est. completion date: December 2006

Study information

• Verified date: February 2012
• 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 evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)

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: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipoproteinemia Type III
• Hyperlipoproteinemias

Intervention

Drug:
• torcetrapib/atorvastatin

• atorvastatin

• fenofibrate

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Quebec
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Huntington Beach	California
United States	Pfizer Investigational Site	Longwood	Florida
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Pacific Palisades	California
United States	Pfizer Investigational Site	Portage	Michigan
United States	Pfizer Investigational Site	Portage	Michigan
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Scarborough	Maine
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Studio City	California
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tripler Army Medical Center	Hawaii
United States	Pfizer Investigational Site	Tustin	California
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 LDL-C and non-HDL-C levels.
Secondary	Changes in other lipid and biomarker variable levels.