Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
RADIANCE 1
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.
1 other identifier
interventional
800
8 countries
34
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 heterozygous familial hypercholesterolemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2003
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedApril 22, 2015
April 1, 2015
August 25, 2005
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in intima media thickness as measures by carotid ultrasound
Secondary Outcomes (1)
Changes in levels of lipids and other biomarkers.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Heterozygous Familial Hypercholesterolemia
- 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 (34)
Pfizer Investigational Site
Hartford, Connecticut, United States
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
Houston, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, 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
OYS, Finland
Pfizer Investigational Site
Paris, France
Pfizer Investigational Site
Toul, France
Pfizer Investigational Site
Brescia, Italy
Pfizer Investigational Site
Pavia, Italy
Pfizer Investigational Site
Alkmaar, Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands
Pfizer Investigational Site
Delft, Netherlands
Pfizer Investigational Site
Goes, Netherlands
Pfizer Investigational Site
Groningen, Netherlands
Pfizer Investigational Site
Hoorn, Netherlands
Pfizer Investigational Site
Leiden, Netherlands
Pfizer Investigational Site
Nijmegen, Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands
Pfizer Investigational Site
Sliedrecht, Netherlands
Pfizer Investigational Site
Utrecht, Netherlands
Pfizer Investigational Site
Waalwijk, Netherlands
Pfizer Investigational Site
Parow, Cape Town, South Africa
Pfizer Investigational Site
Parktown, Johannesburg, South Africa
Pfizer Investigational Site
Cape Town, South Africa
Related Publications (6)
Tajik 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: 21613319DERIVEDDogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.
PMID: 20645885DERIVEDDogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. doi: 10.5551/jat.3269. Epub 2010 Mar 13.
PMID: 20228610DERIVEDVergeer 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: 19029469DERIVEDKastelein 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: 17407645DERIVEDKastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH, Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots ML; RADIANCE 1 Investigators. Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. N Engl J Med. 2007 Apr 19;356(16):1620-30. doi: 10.1056/NEJMoa071359. Epub 2007 Mar 26.
PMID: 17387131DERIVED
Related Links
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
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
December 1, 2003
Study Completion
November 1, 2006
Last Updated
April 22, 2015
Record last verified: 2015-04