RADIANCE 1

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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.

Sponsor

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
Study Arms
Population Size	800 subjects

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

Outcomes

Primary Outcomes

• Change in intima media thickness as measures by carotid ultrasound

Secondary Outcomes

• Changes in levels of lipids and other biomarkers

Publications

Conclusion

Pending