Clinical trial NCT00145431: Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.
Official title: Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hyperlipoproteinemia Type III
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

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

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)

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

Primary outcomes:
measure: Change in LDL-C and non-HDL-C levels.
Secondary outcomes:
measure: Changes in other lipid and biomarker variable levels.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Pacific Palisades
country: United States
facility: Pfizer Investigational Site
state: California
city: Studio City
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Longwood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tripler Army Medical Center
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: West Seneca
country: United States
facility: Pfizer Investigational Site
state: New York
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
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: Quebec
country: Canada
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: