Clinical trial NCT00134498: A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
Official title: Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Hyperlipoproteinemia Type IV
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 160
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 assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

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

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Fredrickson Type IV Hypertriglyceridemia

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 HDL-C and non-HDL-C levels
Secondary outcomes:
measure: Changes in levels of other lipid and biomarkers.
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: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Orangevale
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: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Longwood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
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: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Richland
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: St. Cloud
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
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: Statesville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
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: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: