Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00139061
• Date of registration: 26/08/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
• Scientific 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
• Date of first enrolment: March 2005
• Target sample size: 128
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00139061
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperlipidemia

Intervention(s)

Drug: Fenofibrate

Drug: Torcetrapib/Atorvastatin

Primary Outcome(s)

To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.

Secondary Outcome(s)

Changes in levels of lipid parameters and other biomarkers

Secondary ID(s)

A5091034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors