Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin.
RADIANCE 2
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 Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
1 other identifier
interventional
755
6 countries
51
Brief Summary
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 mixed hyperlipidemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2003
Typical duration for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 17, 2012
February 1, 2012
3.1 years
August 22, 2005
February 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in intima media thickness as measured by carotid ultrasound
Secondary Outcomes (1)
Changes in levels of lipids and other biomarkers.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of mixed hyperlipidemia
- At least 18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (51)
Pfizer Investigational Site
Gilbert, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Alhambra, California, United States
Pfizer Investigational Site
Encinitas, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Hartford, Connecticut, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
Palm Bay, Florida, United States
Pfizer Investigational Site
Sebastian, Florida, United States
Pfizer Investigational Site
Stuart, Florida, United States
Pfizer Investigational Site
Vero Beach, Florida, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Cambridge, Massachusetts, United States
Pfizer Investigational Site
Edina, Minnesota, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Concord, New Hampshire, United States
Pfizer Investigational Site
Bronxville, New York, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
Mount Vernon, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Williamsville, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Newport News, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Bothell, Washington, United States
Pfizer Investigational Site
Kirkland, Washington, United States
Pfizer Investigational Site
Renton, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Kuopio, Finland
Pfizer Investigational Site
Paris, France
Pfizer Investigational Site
Nijmegen, Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands
Pfizer Investigational Site
Utrecht, Netherlands
Related Publications (5)
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PMID: 37565307DERIVEDTajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.
PMID: 21613319DERIVEDVergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24.
PMID: 19029469DERIVEDBots ML, Visseren FL, Evans GW, Riley WA, Revkin JH, Tegeler CH, Shear CL, Duggan WT, Vicari RM, Grobbee DE, Kastelein JJ; RADIANCE 2 Investigators. Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial. Lancet. 2007 Jul 14;370(9582):153-160. doi: 10.1016/S0140-6736(07)61088-5.
PMID: 17630038DERIVEDKastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94. doi: 10.1185/030079907x182121.
PMID: 17407645DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
November 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 17, 2012
Record last verified: 2012-02