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

Mixed Hyperlipidemia Clinical Trial

— RADIANCE 2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00134238
• Other study ID #: A5091004
• Status: Terminated
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: February 15, 2012
• Start date: November 2003
• Est. completion date: December 2006

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 755
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipidemia

Intervention

Drug:
• torcetrapib/atorvastatin

• atorvastatin

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Czech Republic	Pfizer Investigational Site	Prague 4
Finland	Pfizer Investigational Site	Kuopio
France	Pfizer Investigational Site	Paris Cedex
Netherlands	Pfizer Investigational Site	Nijmegen
Netherlands	Pfizer Investigational Site	Rotterdam
Netherlands	Pfizer Investigational Site	Utrecht
United States	Pfizer Investigational Site	Alhambra	California
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bothell	Washington
United States	Pfizer Investigational Site	Bronxville	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Cambridge	Massachusetts
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Concord	New Hampshire
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Encinitas	California
United States	Pfizer Investigational Site	Gilbert	Arizona
United States	Pfizer Investigational Site	Hartford	Connecticut
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Mount Vernon	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport News	Virginia
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Palm Bay	Florida
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Seattle	Washington
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	Williamsville	New York
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Finland,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intima media thickness as measured by carotid ultrasound
Secondary	Changes in levels of lipids and other biomarkers.