Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.
Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
1 other identifier
interventional
41
2 countries
27
Brief Summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2005
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 17, 2012
February 1, 2012
1.8 years
August 31, 2005
February 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in LDL-C and non-HDL-C levels.
Secondary Outcomes (1)
Changes in other lipid and biomarker variable levels.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)
You may not qualify if:
- 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
- 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 evaluation of response, or render unlikely that the subject would complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Pfizer Investigational Site
Anaheim, California, 92804, United States
Pfizer Investigational Site
Huntington Beach, California, 92648, United States
Pfizer Investigational Site
Orange, California, 92868, United States
Pfizer Investigational Site
Pacific Palisades, California, 90272, United States
Pfizer Investigational Site
Studio City, California, 91604, United States
Pfizer Investigational Site
Tustin, California, 92780, United States
Pfizer Investigational Site
Hollywood, Florida, 33021, United States
Pfizer Investigational Site
Longwood, Florida, 32779, United States
Pfizer Investigational Site
Tripler Army Medical Center, Hawaii, 96859-5000, United States
Pfizer Investigational Site
Scarborough, Maine, 04074, United States
Pfizer Investigational Site
Portage, Michigan, 49002, United States
Pfizer Investigational Site
Portage, Michigan, 49024, United States
Pfizer Investigational Site
Olive Branch, Mississippi, 38654, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Syracuse, New York, 13210, United States
Pfizer Investigational Site
West Seneca, New York, 14224, United States
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960, United States
Pfizer Investigational Site
Greer, South Carolina, 29651, United States
Pfizer Investigational Site
Memphis, Tennessee, 38105, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84108, United States
Pfizer Investigational Site
Seattle, Washington, 98104, United States
Pfizer Investigational Site
Madison, Wisconsin, 53719, United States
Pfizer Investigational Site
London, Ontario, N6A 5K8, Canada
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6, Canada
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8, Canada
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7, Canada
Pfizer Investigational Site
Québec, Quebec, G1V 4M6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 5, 2005
Study Start
March 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 17, 2012
Record last verified: 2012-02