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Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin. (RADIANCE 2)

Primary Purpose

Mixed Hyperlipidemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
torcetrapib/atorvastatin
atorvastatin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Hyperlipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Change in intima media thickness as measured by carotid ultrasound

Secondary Outcome Measures

Changes in levels of lipids and other biomarkers.

Full Information

First Posted
August 22, 2005
Last Updated
February 15, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00134238
Brief Title
Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. 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 mixed hyperlipidemia
Detailed Description
For additional information please call: 1-800-718-1021

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
755 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
torcetrapib/atorvastatin
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Primary Outcome Measure Information:
Title
Change in intima media thickness as measured by carotid ultrasound
Secondary Outcome Measure Information:
Title
Changes in levels of lipids and other biomarkers.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Alhambra
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Encinitas
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Bay
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Sebastian
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Stuart
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Cambridge
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Edina
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Concord
State/Province
New Hampshire
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronxville
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Vernon
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Williamsville
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Bothell
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Prague 4
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Kuopio
Country
Finland
Facility Name
Pfizer Investigational Site
City
Paris Cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21613319
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.
Results Reference
derived
PubMed Identifier
19029469
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. Erratum In: Circulation. 2009 Feb 10;119(5):e197.
Results Reference
derived
PubMed Identifier
17630038
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.
Results Reference
derived
PubMed Identifier
17407645
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.
Results Reference
derived

Learn more about this trial

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

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