Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.

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 look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia

Official title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 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 intima media thickness as measures by carotid ultrasound

Secondary outcome: Changes in levels of lipids and other biomarkers.

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

Minimum age: 18 Years. Maximum age: 70 Years. 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 evaluationof response, or render unlikely that the subject would complete the study

Pfizer Investigational Site, Quebec, Canada

Pfizer Investigational Site, Prague 4, Czech Republic

Pfizer Investigational Site, Kuopio, Finland

Pfizer Investigational Site, OYS, Finland

Pfizer Investigational Site, 75651 PARIS Cedex 13, France

Pfizer Investigational Site, 54201 Toul Cedex, France

Pfizer Investigational Site, PAVIA, Italy

Pfizer Investigational Site, Brescia, Italy

Pfizer Investigational Site, UTRECHT, Netherlands

Pfizer Investigational Site, WAALWIJK, Netherlands

Pfizer Investigational Site, ROTTERDAM, Netherlands

Pfizer Investigational Site, HOORN, Netherlands

Pfizer Investigational Site, Leiden, Netherlands

Pfizer Investigational Site, Delft, Netherlands

Pfizer Investigational Site, ALKMAAR, Netherlands

Pfizer Investigational Site, Goes, Netherlands

Pfizer Investigational Site, SLIEDRECHT, Netherlands

Pfizer Investigational Site, Groningen, Netherlands

Pfizer Investigational Site, AMSTERDAM, Netherlands

Pfizer Investigational Site, Nijmegen, Netherlands

Pfizer Investigational Site, Cape Town, South Africa

Pfizer Investigational Site, Vancouver, British Columbia, Canada

Pfizer Investigational Site, Parow, Cape Town, South Africa

Pfizer Investigational Site, Hartford, Connecticut, United States

Pfizer Investigational Site, Parktown, Johannesburg, South Africa

Pfizer Investigational Site, Winnipeg, Manitoba, Canada

Pfizer Investigational Site, Boston, Massachusetts, United States

Pfizer Investigational Site, Minneapolis, Minnesota, United States

Pfizer Investigational Site, New York, New York, United States

Pfizer Investigational Site, 128 21, Prague 2, Czech Republic

Pfizer Investigational Site, CHICOUTIMI, Quebec, Canada

Pfizer Investigational Site, MONTREAL, Quebec, Canada

Pfizer Investigational Site, Houston, Texas, United States

Pfizer Investigational Site, Salt Lake City, Utah, United States

Pfizer Investigational Site, Seattle, Washington, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting:

Starting date: December 2003
Ending date: November 2006
Last updated: May 18, 2007