Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00134485
• Date of registration: 22/08/2005
• Primary sponsor: Pfizer
• Public title: Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
• Scientific 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
• Date of first enrolment: March 2005
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00134485
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Australia, Canada, Denmark, France, Iceland, Norway, South Africa, Sweden, United States

Contacts

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

Key inclusion & exclusion 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



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

Health Condition(s) or Problem(s) studied

Hypercholesterolemia, Familial

Hyperlipidemia

Intervention(s)

Drug: atorvastatin

Drug: torcetrapib/atorvastatin

Primary Outcome(s)

Change in HDL-C and LDL-C

Secondary Outcome(s)

Changes in other lipid parameters

Secondary ID(s)

A5091026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors