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A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.

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ClinicalTrials.gov Identifier: NCT00267267
Recruitment Status : Terminated
First Posted : December 20, 2005
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.


Condition or disease Intervention/treatment Phase
Hyperlipidemia Dyslipidemia Drug: torcetrapib/atorvastatin Drug: ezetimibe/simvastatin Phase 3

Detailed Description:
For additional information please call: 1-800-718-1021

Study Type : Interventional  (Clinical Trial)
Enrollment : 1784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.
Study Start Date : January 2006
Actual Study Completion Date : January 2007





Primary Outcome Measures :
  1. Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.

Secondary Outcome Measures :
  1. Changes in other lipid parameters and other biomarkers.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Specific LDL-C levels based on CHD risk after a six-week washout period.

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • Subjects requiring systemic steroids
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267267


  Show 123 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00267267     History of Changes
Other Study ID Numbers: A5091035
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: December 10, 2007
Last Verified: December 2006

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Torcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors