Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone. (RADIANCE 1)

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ClinicalTrials.gov Identifier: NCT00136981

Recruitment Status : Completed

First Posted : August 29, 2005

Last Update Posted : April 22, 2015

Sponsor:

Information provided by:

Pfizer

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia, Familial Hyperlipidemia	Drug: torcetrapib/atorvastatin Drug: atorvastatin	Phase 3

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	800 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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 Start Date :	December 2003
Actual Study Completion Date :	November 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial hypercholesterolemia

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know Ultrasound

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Change in intima media thickness as measures by carotid ultrasound

Secondary Outcome Measures :

Changes in levels of lipids and other biomarkers.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136981

Locations

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United States, Connecticut
Pfizer Investigational Site
Hartford, Connecticut, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States
United States, New York
Pfizer Investigational Site
New York, New York, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Canada
Pfizer Investigational Site
Quebec, Canada
Czech Republic
Pfizer Investigational Site
Prague 4, Czech Republic
Pfizer Investigational Site
Prague, Czech Republic
Finland
Pfizer Investigational Site
Kuopio, Finland
Pfizer Investigational Site
OYS, Finland
France
Pfizer Investigational Site
PARIS Cedex, France
Pfizer Investigational Site
Toul Cedex, France
Italy
Pfizer Investigational Site
Brescia, Italy
Pfizer Investigational Site
Pavia, Italy
Netherlands
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
South Africa
Pfizer Investigational Site
Parow, Cape Town, South Africa
Pfizer Investigational Site
Parktown, Johannesburg, South Africa
Pfizer Investigational Site
Cape Town, South Africa

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Dogan 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.

Dogan 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. Epub 2010 Mar 13.

Vergeer 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. Erratum in: Circulation. 2009 Feb 10;119(5):e197.

Kastelein 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.

Kastelein 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. Epub 2007 Mar 26.

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ClinicalTrials.gov Identifier:	NCT00136981
Other Study ID Numbers:	A5091003
First Posted:	August 29, 2005 Key Record Dates
Last Update Posted:	April 22, 2015
Last Verified:	April 2015

Additional relevant MeSH terms:

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Hyperlipoproteinemia Type II Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hyperlipoproteinemias Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn	Atorvastatin Torcetrapib Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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