Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin.

NCT ID: NCT00134238

Last Updated: 2012-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

755 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-12-31

Brief Summary

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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

Detailed Description

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

Conditions

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Mixed Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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torcetrapib/atorvastatin

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of mixed hyperlipidemia
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Alhambra, California, United States

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Encinitas, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Hartford, Connecticut, United States

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Melbourne, Florida, United States

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Palm Bay, Florida, United States

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Sebastian, Florida, United States

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Stuart, Florida, United States

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Vero Beach, Florida, United States

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Overland Park, Kansas, United States

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Boston, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Concord, New Hampshire, United States

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Bronxville, New York, United States

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Buffalo, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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Williamsville, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Bothell, Washington, United States

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Kirkland, Washington, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Prague, , Czechia

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Kuopio, , Finland

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Paris, , France

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Countries

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United States Canada Czechia Finland France Netherlands

References

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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.

Reference Type DERIVED
PMID: 37565307 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21613319 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19029469 (View on PubMed)

Bots 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.

Reference Type DERIVED
PMID: 17630038 (View on PubMed)

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. doi: 10.1185/030079907x182121.

Reference Type DERIVED
PMID: 17407645 (View on PubMed)

Other Identifiers

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A5091004

Identifier Type: -

Identifier Source: org_study_id

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