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

Condition(s) targeted: Hypercholesterolemia, Familial; Hyperlipidemia

Intervention: torcetrapib/atorvastatin (Drug); atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HDL-C and LDL-C

Secondary outcome: Changes in other lipid parameters

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Darlinghurst NSW 2010, Australia

Pfizer Investigational Site, Arhus C 8000, Denmark

Pfizer Investigational Site, Aalborg 9000, Denmark

Pfizer Investigational Site, Paris 75651 Cedex 13, France

Pfizer Investigational Site, Dijon 21000, France

Pfizer Investigational Site, Nantes cedex 01 44093, France

Pfizer Investigational Site, Kopavogur 201, Iceland

Pfizer Investigational Site, Oslo 0027, Norway

Pfizer Investigational Site, Oslo 0407, Norway

Pfizer Investigational Site, Bloemfontein 9301, South Africa

Pfizer Investigational Site, Cape Town 7925, South Africa

Pfizer Investigational Site, Linkoping 581 85, Sweden

Pfizer Investigational Site, Goteborg 413 45, Sweden

Pfizer Investigational Site, Stockholm 141 86, Sweden

Pfizer Investigational Site, Malmo 205 02, Sweden

Pfizer Investigational Site, San Diego, California 92120, United States

Pfizer Investigational Site, Parow, Cape Town 7500, South Africa

Pfizer Investigational Site, Washington, District of Columbia 20037, United States

Pfizer Investigational Site, Lutz, Florida 33549, United States

Pfizer Investigational Site, Tampa, Florida 33603, United States

Pfizer Investigational Site, Tripler AMC, Hawaii 96859-5000, United States

Pfizer Investigational Site, Chicago, Illinois 60610, United States

Pfizer Investigational Site, Indianapolis, Indiana 46260, United States

Pfizer Investigational Site, Iowa City, Iowa 52242, United States

Pfizer Investigational Site, Unknown, Lille 59037, France

Pfizer Investigational Site, Scarborough, Maine 04074, United States

Pfizer Investigational Site, Auburn, Maine 04210, United States

Pfizer Investigational Site, Boston, Massachusetts 02111, United States

Pfizer Investigational Site, Camperdown, New South Wales 2050, Australia

Pfizer Investigational Site, Charlotte, North Carolina 28204, United States

Pfizer Investigational Site, Montreal, Quebec H2W 1R7, Canada

Pfizer Investigational Site, Ste-Foy, Quebec G1V 4M6, Canada

Pfizer Investigational Site, Chicoutimi, Quebec G7H 5H6, Canada

Pfizer Investigational Site, Montreal, Quebec H1T 1C8, Canada

Pfizer Investigational Site, Woolloongabba, Queensland 4102, Australia

Pfizer Investigational Site, North Adelaide, South Australia 5006, Australia

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Clayton, Victoria 3168, Australia

Pfizer Investigational Site, Perth, Western Australia 6000, Australia

Pfizer Investigational Site, Bellville, Western Cape 7531, South Africa

Pfizer Investigational Site, Madison, Wisconsin 53719, United States

Links to ClinicalStudyResults.org Posting:

Starting date: March 2005
Ending date: March 2006
Last updated: October 28, 2007