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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

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.

Objective

The objective of this study is 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. The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Pfizer

Timeline

Timeline
Start Date December 2003
End Date November 2006
Status Terminated on December 2, 2006 due to safety findings

The previous information was derived from ClinicalTrials.gov on 08/18/2014 using the identification number NCT00136981.

Study Description

Study Description
Study Type Interventional
Study Phase Phase 3
Study Design
Allocation Randomized
Endpoint Safety/Efficacy Study
Interventional Model Parallel Assignment
Masking Double-Blind
Study Details
Primary Purpose Treatment
Condition Hypercholesterolemia, familial hyperlipidemia
Intervention Drug: torcetrapib/atorvastatin
Drug: atorvastatin
Population Size 800 subjects

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00136981.

Eligibility 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

Outcomes

Primary Outcomes

  • Change in intima media thickness as measures by carotid ultrasound

Secondary Outcomes

  • Changes in levels of lipids and other biomarkers

Publications

The administration of torcetrapib with atorvastatin among patients with familial hypercholesterolemia did not lead to decrease in the progression of atherosclerosis as compared with atorvastatin alone.[1]

References

  1. Kastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ; et al. (2007). "Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia". N Engl J Med. 356 (16): 1620–30. doi:10.1056/NEJMoa071359. PMID 17387131.

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