Clinical trial NCT00134238: Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin.
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 Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Mixed Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 755
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in intima media thickness as measured by carotid ultrasound
Secondary outcomes:
measure: Changes in levels of lipids and other biomarkers.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Alhambra
country: United States
facility: Pfizer Investigational Site
state: California
city: Encinitas
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Bay
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sebastian
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Cambridge
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Concord
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Bronxville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Newport News
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Bothell
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Prague 4
country: Czech Republic
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Paris Cedex
country: France
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.