A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
1 other identifier
interventional
160
2 countries
44
Brief Summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2005
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedNovember 16, 2007
March 1, 2007
August 22, 2005
November 15, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HDL-C and non-HDL-C levels
Secondary Outcomes (1)
Changes in levels of other lipid and biomarkers.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Fredrickson Type IV Hypertriglyceridemia
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 (44)
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Huntington Beach, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Orangevale, California, United States
Pfizer Investigational Site
Pacific Palisades, California, United States
Pfizer Investigational Site
Studio City, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Walnut Creek, California, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Longwood, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Tripler AMC, Hawaii, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
Pfizer Investigational Site
Scarborough, Maine, United States
Pfizer Investigational Site
Bethesda, Maryland, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Canton, Michigan, United States
Pfizer Investigational Site
Portage, Michigan, United States
Pfizer Investigational Site
Richland, Michigan, United States
Pfizer Investigational Site
Saint Cloud, Minnesota, United States
Pfizer Investigational Site
Olive Branch, Mississippi, United States
Pfizer Investigational Site
Jefferson City, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
West Seneca, New York, United States
Pfizer Investigational Site
Statesville, North Carolina, United States
Pfizer Investigational Site
Sellersville, Pennsylvania, United States
Pfizer Investigational Site
Warwick, Rhode Island, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Pfizer Investigational Site
London, Ontario, Canada
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Ste-Foy, Quebec, Canada
Related Links
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
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
February 1, 2005
Study Completion
November 1, 2006
Last Updated
November 16, 2007
Record last verified: 2007-03