NCT00139061CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 128
- Locations
- 26
- Primary Endpoint
- To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Study Overview
Brief Summary
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.
Detailed Description
For additional information please call: 1-800-718-1021
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary Outcomes
- Changes in levels of lipid parameters and other biomarkers
Investigators
Study Sites (26)
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