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

Primary Purpose

Hypercholesterolemia, Familial, Hyperlipidemia

Status
Completed
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 Hypercholesterolemia, Familial

Eligibility Criteria

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

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

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

Outcomes

Primary Outcome Measures

Change in intima media thickness as measures by carotid ultrasound

Secondary Outcome Measures

Changes in levels of lipids and other biomarkers.

Full Information

First Posted
August 25, 2005
Last Updated
April 21, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00136981
Brief Title
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
Acronym
RADIANCE 1
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

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 heterozygous familial hypercholesterolemia
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
Hypercholesterolemia, Familial, Hyperlipidemia

7. Study Design

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

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 measures 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 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
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
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
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
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
Prague
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Kuopio
Country
Finland
Facility Name
Pfizer Investigational Site
City
OYS
Country
Finland
Facility Name
Pfizer Investigational Site
City
PARIS Cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Toul Cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Brescia
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
Country
Italy
Facility Name
Pfizer Investigational Site
City
Alkmaar
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Delft
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Goes
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Groningen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hoorn
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leiden
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Sliedrecht
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Utrecht
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Waalwijk
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Parow
State/Province
Cape Town
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
State/Province
Johannesburg
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
Country
South Africa

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
20645885
Citation
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.
Results Reference
derived
PubMed Identifier
20228610
Citation
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. doi: 10.5551/jat.3269. Epub 2010 Mar 13.
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
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
PubMed Identifier
17387131
Citation
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. doi: 10.1056/NEJMoa071359. Epub 2007 Mar 26.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5091003&StudyName=Carotid+B%2DMode+Ultrasound+Study+to+Compare+Anti%2DAtherosclerotic+Effect+of+Torcetrpib%2FAtorvastatin+to+Atorvastatin+Alone%2E
Description
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Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.

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