Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00134485
First received: August 22, 2005
Last updated: October 28, 2007
Last verified: December 2006
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia, Familial Hyperlipidemia |
Drug: torcetrapib/atorvastatin Drug: atorvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
Further study details as provided by Pfizer:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134485
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| United States, California | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92120 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Lutz, Florida, United States, 33549 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33603 | |
| United States, Hawaii | |
| Pfizer Investigational Site | |
| Tripler AMC, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maine | |
| Pfizer Investigational Site | |
| Auburn, Maine, United States, 04210 | |
| Pfizer Investigational Site | |
| Scarborough, Maine, United States, 04074 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02111 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53719 | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Clayton, Victoria, Australia, 3168 | |
| Australia, Western Australia | |
| Pfizer Investigational Site | |
| Perth, Western Australia, Australia, 6000 | |
| Australia | |
| Pfizer Investigational Site | |
| Darlinghurst, Australia, NSW 2010 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2W 1R7 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Pfizer Investigational Site | |
| Ste-Foy, Quebec, Canada, G1V 4M6 | |
| Denmark | |
| Pfizer Investigational Site | |
| Aalborg, Denmark, 9000 | |
| Pfizer Investigational Site | |
| Arhus C, Denmark, 8000 | |
| France | |
| Pfizer Investigational Site | |
| Unknown, Lille, France, 59037 | |
| Pfizer Investigational Site | |
| Dijon, France, 21000 | |
| Pfizer Investigational Site | |
| Nantes cedex 01, France, 44093 | |
| Pfizer Investigational Site | |
| Paris, France, 75651 Cedex 13 | |
| Iceland | |
| Pfizer Investigational Site | |
| Kopavogur, Iceland, 201 | |
| Norway | |
| Pfizer Investigational Site | |
| Oslo, Norway, 0027 | |
| Pfizer Investigational Site | |
| Oslo, Norway, 0407 | |
| South Africa | |
| Pfizer Investigational Site | |
| Parow, Cape Town, South Africa, 7500 | |
| Pfizer Investigational Site | |
| Bellville, Western Cape, South Africa, 7531 | |
| Pfizer Investigational Site | |
| Bloemfontein, South Africa, 9301 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7925 | |
| Sweden | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 413 45 | |
| Pfizer Investigational Site | |
| Linkoping, Sweden, 581 85 | |
| Pfizer Investigational Site | |
| Malmo, Sweden, 205 02 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 141 86 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00134485 History of Changes |
| Other Study ID Numbers: | A5091026 |
| Study First Received: | August 22, 2005 |
| Last Updated: | October 28, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias Atorvastatin |
Torcetrapib Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013