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NCT00136981 Clinical Trial

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

Hyperlipidemia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00136981
Other study ID # A5091003
Secondary ID
Status Completed
Phase Phase 3
First received August 25, 2005
Last updated April 21, 2015
Start date December 2003
Est. completion date November 2006

Study information
Verified date April 2015
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 heterozygous familial hypercholesterolemia

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

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
Czech Republic Pfizer Investigational Site Prague 4
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site OYS
France Pfizer Investigational Site PARIS Cedex
France Pfizer Investigational Site Toul Cedex
Italy Pfizer Investigational Site Brescia
Italy Pfizer Investigational Site Pavia
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
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Parktown Johannesburg
South Africa Pfizer Investigational Site Parow Cape Town
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Hartford Connecticut
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Finland,  France,  Italy,  Netherlands,  South Africa, 

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