Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia
1 other identifier
interventional
400
9 countries
40
Brief Summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
Shorter than P25 for phase_3
40 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 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedOctober 30, 2007
December 1, 2006
August 22, 2005
October 28, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HDL-C and LDL-C
Secondary Outcomes (1)
Changes in other lipid parameters
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Heterozygous Familial Hypercholesterolemia
- At least 18 years of age
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 (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 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 (41)
Pfizer Investigational Site
San Diego, California, 92120, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037, United States
Pfizer Investigational Site
Lutz, Florida, 33549, United States
Pfizer Investigational Site
Tampa, Florida, 33603, United States
Pfizer Investigational Site
Tripler AMC, Hawaii, 96859-5000, United States
Pfizer Investigational Site
Chicago, Illinois, 60610, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46260, United States
Pfizer Investigational Site
Iowa City, Iowa, 52242, United States
Pfizer Investigational Site
Auburn, Maine, 04210, United States
Pfizer Investigational Site
Scarborough, Maine, 04074, United States
Pfizer Investigational Site
Boston, Massachusetts, 02111, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28204, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Madison, Wisconsin, 53719, United States
Pfizer Investigational Site
Camperdown, New South Wales, 2050, Australia
Pfizer Investigational Site
Woolloongabba, Queensland, 4102, Australia
Pfizer Investigational Site
North Adelaide, South Australia, 5006, Australia
Pfizer Investigational Site
Clayton, Victoria, 3168, Australia
Pfizer Investigational Site
Perth, Western Australia, 6000, Australia
Pfizer Investigational Site
Darlinghurst, NSW 2010, Australia
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
Ste-Foy, Quebec, G1V 4M6, Canada
Pfizer Investigational Site
Aalborg, 9000, Denmark
Pfizer Investigational Site
Arhus C, 8000, Denmark
Pfizer Investigational Site
Dijon, 21000, France
Pfizer Investigational Site
Nantes, 44093, France
Pfizer Investigational Site
Paris, 75651 Cedex 13, France
Pfizer Investigational Site
Kopavogur, 201, Iceland
Pfizer Investigational Site
Oslo, 0027, Norway
Pfizer Investigational Site
Oslo, 0407, Norway
Pfizer Investigational Site
Parow, Cape Town, 7500, South Africa
Pfizer Investigational Site
Bellville, Western Cape, 7531, South Africa
Pfizer Investigational Site
Bloemfontein, 9301, South Africa
Pfizer Investigational Site
Cape Town, 7925, South Africa
Pfizer Investigational Site
Gothenburg, 413 45, Sweden
Pfizer Investigational Site
Linköping, 581 85, Sweden
Pfizer Investigational Site
Malmo, 205 02, Sweden
Pfizer Investigational Site
Stockholm, 141 86, Sweden
Pfizer Investigational Site
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
March 1, 2005
Study Completion
March 1, 2006
Last Updated
October 30, 2007
Record last verified: 2006-12