Clinical trial NCT00134485: Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia, Familial
Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

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

Eligibility 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

Primary outcomes:
measure: Change in HDL-C and LDL-C
Secondary outcomes:
measure: Changes in other lipid parameters
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Lutz
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tripler AMC
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Auburn
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: North Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Arhus C
country: Denmark
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Nantes cedex 01
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Kopavogur
country: Iceland
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Bellville
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: