Hyperlipidemia Clinical Trial
Official title:
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
Verified date | December 2006 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 400 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
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 evaluation of response, or render unlikely that the subject would complete the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Pfizer Investigational Site | Camperdown | New South Wales |
Australia | Pfizer Investigational Site | Clayton | Victoria |
Australia | Pfizer Investigational Site | Darlinghurst | |
Australia | Pfizer Investigational Site | North Adelaide | South Australia |
Australia | Pfizer Investigational Site | Perth | Western Australia |
Australia | Pfizer Investigational Site | Woolloongabba | Queensland |
Canada | Pfizer Investigational Site | Chicoutimi | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Ste-Foy | Quebec |
Denmark | Pfizer Investigational Site | Aalborg | |
Denmark | Pfizer Investigational Site | Arhus C | |
France | Pfizer Investigational Site | Dijon | |
France | Pfizer Investigational Site | Nantes cedex 01 | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Unknown | Lille |
Iceland | Pfizer Investigational Site | Kopavogur | |
Norway | Pfizer Investigational Site | Oslo | |
Norway | Pfizer Investigational Site | Oslo | |
South Africa | Pfizer Investigational Site | Bellville | Western Cape |
South Africa | Pfizer Investigational Site | Bloemfontein | |
South Africa | Pfizer Investigational Site | Cape Town | |
South Africa | Pfizer Investigational Site | Parow | Cape Town |
Sweden | Pfizer Investigational Site | Goteborg | |
Sweden | Pfizer Investigational Site | Linkoping | |
Sweden | Pfizer Investigational Site | Malmo | |
Sweden | Pfizer Investigational Site | Stockholm | |
United States | Pfizer Investigational Site | Auburn | Maine |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Charlotte | North Carolina |
United States | Pfizer Investigational Site | Chicago | Illinois |
United States | Pfizer Investigational Site | Houston | Texas |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Iowa City | Iowa |
United States | Pfizer Investigational Site | Lutz | Florida |
United States | Pfizer Investigational Site | Madison | Wisconsin |
United States | Pfizer Investigational Site | San Diego | California |
United States | Pfizer Investigational Site | Scarborough | Maine |
United States | Pfizer Investigational Site | Tampa | Florida |
United States | Pfizer Investigational Site | Tripler AMC | Hawaii |
United States | Pfizer Investigational Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Canada, Denmark, France, Iceland, Norway, South Africa, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HDL-C and LDL-C | |||
Secondary | Changes in other lipid parameters |
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