Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia

Hyperlipidemia Clinical Trial

Official title:

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134485
• Other study ID #: A5091026
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: October 28, 2007
• Start date: March 2005
• Est. completion date: March 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 evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Heterozygous Familial Hypercholesterolemia

• At least 18 years of age

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 (high doses)

• 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

• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemia Type II

Intervention

Drug:
• torcetrapib/atorvastatin

• atorvastatin

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Clayton	Victoria
Australia	Pfizer Investigational Site	Darlinghurst
Australia	Pfizer Investigational Site	North Adelaide	South Australia
Australia	Pfizer Investigational Site	Perth	Western Australia
Australia	Pfizer Investigational Site	Woolloongabba	Queensland
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ste-Foy	Quebec
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Arhus C
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Nantes cedex 01
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Unknown	Lille
Iceland	Pfizer Investigational Site	Kopavogur
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Oslo
South Africa	Pfizer Investigational Site	Bellville	Western Cape
South Africa	Pfizer Investigational Site	Bloemfontein
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Parow	Cape Town
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Stockholm
United States	Pfizer Investigational Site	Auburn	Maine
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	Lutz	Florida
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Scarborough	Maine
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tripler AMC	Hawaii
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  France,  Iceland,  Norway,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HDL-C and LDL-C
Secondary	Changes in other lipid parameters