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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136981
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Pfizer

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


Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Hyperlipidemia Drug: torcetrapib/atorvastatin Drug: atorvastatin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2003
Actual Study Completion Date : November 2006





Primary Outcome Measures :
  1. Change in intima media thickness as measures by carotid ultrasound

Secondary Outcome Measures :
  1. Changes in levels of lipids and other biomarkers.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136981


Locations
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United States, Connecticut
Pfizer Investigational Site
Hartford, Connecticut, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States
United States, New York
Pfizer Investigational Site
New York, New York, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Canada
Pfizer Investigational Site
Quebec, Canada
Czech Republic
Pfizer Investigational Site
Prague 4, Czech Republic
Pfizer Investigational Site
Prague, Czech Republic
Finland
Pfizer Investigational Site
Kuopio, Finland
Pfizer Investigational Site
OYS, Finland
France
Pfizer Investigational Site
PARIS Cedex, France
Pfizer Investigational Site
Toul Cedex, France
Italy
Pfizer Investigational Site
Brescia, Italy
Pfizer Investigational Site
Pavia, Italy
Netherlands
Pfizer Investigational Site
Alkmaar, Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands
Pfizer Investigational Site
Delft, Netherlands
Pfizer Investigational Site
Goes, Netherlands
Pfizer Investigational Site
Groningen, Netherlands
Pfizer Investigational Site
Hoorn, Netherlands
Pfizer Investigational Site
Leiden, Netherlands
Pfizer Investigational Site
Nijmegen, Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands
Pfizer Investigational Site
Sliedrecht, Netherlands
Pfizer Investigational Site
Utrecht, Netherlands
Pfizer Investigational Site
Waalwijk, Netherlands
South Africa
Pfizer Investigational Site
Parow, Cape Town, South Africa
Pfizer Investigational Site
Parktown, Johannesburg, South Africa
Pfizer Investigational Site
Cape Town, South Africa
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00136981    
Other Study ID Numbers: A5091003
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Atorvastatin
Torcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors