Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139061
First received: August 26, 2005
Last updated: October 30, 2007
Last verified: December 2006
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Purpose
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia |
Drug: Torcetrapib/Atorvastatin Drug: Fenofibrate |
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, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary Outcome Measures:
- Changes in levels of lipid parameters and other biomarkers
| Estimated Enrollment: | 128 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | May 2006 |
For additional information please call: 1-800-718-1021
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Fredrickson Type IIB dyslipidema (Mixed Hyperlipidemia)
- Men and women 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
- 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: NCT00139061
Locations
| France | |
| Pfizer Investigational Site | |
| Angers, France, 49 000 | |
| Pfizer Investigational Site | |
| Angers, France, 49 100 | |
| Pfizer Investigational Site | |
| Bordeaux Cauderan, France, 33 200 | |
| Pfizer Investigational Site | |
| Briollay, France, 49125 | |
| Pfizer Investigational Site | |
| Dijon, France, 21000 | |
| Pfizer Investigational Site | |
| Hagondange, France, 57 300 | |
| Pfizer Investigational Site | |
| Haut Mauco, France, 40 280 | |
| Pfizer Investigational Site | |
| Jarny, France, 54800 | |
| Pfizer Investigational Site | |
| Lille, France, 59 037 Cedex | |
| Pfizer Investigational Site | |
| Mars LA Tour, France, 54800 | |
| Pfizer Investigational Site | |
| Metz, France, 57070 | |
| Pfizer Investigational Site | |
| Monguilhem, France, 32 240 | |
| Pfizer Investigational Site | |
| Mont de Marsan, France, 40000 | |
| Pfizer Investigational Site | |
| Mont de Marsan, France, 40 010 cedex | |
| Pfizer Investigational Site | |
| Mont de Marsan, France, 40 010 | |
| Pfizer Investigational Site | |
| Mont de Marsan CEDEX, France, 40010 | |
| Pfizer Investigational Site | |
| Moutiers, France, 54660 | |
| Pfizer Investigational Site | |
| Murs Erigne, France, 49610 | |
| Pfizer Investigational Site | |
| Nantes, France, 44 093 Cedex 01 | |
| Pfizer Investigational Site | |
| Pouilly en Auxois, France, 21 850 | |
| Pfizer Investigational Site | |
| Saint Justin, France, 40 240 | |
| Pfizer Investigational Site | |
| Saint Martin D'Oney, France, 40090 | |
| Pfizer Investigational Site | |
| Seysses, France, 31600 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67000 | |
| Pfizer Investigational Site | |
| Thouars, France, 79100 | |
| Pfizer Investigational Site | |
| Tierce, France, 49 125 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00139061 History of Changes |
| Other Study ID Numbers: | A5091034 |
| Study First Received: | August 26, 2005 |
| Last Updated: | October 30, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Fenofibrate Atorvastatin Torcetrapib Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013