Clinical trial NCT00138762: A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol
Official title: A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 3800
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.

A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.

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

Eligibility criteria: Inclusion Criteria:

* subjects with elevated cholesterol

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Intolerance to statin therapy resulting in withdrawal
* 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: LDL and HDL levels
Secondary outcomes:
measure: other lipid parameters
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Oro Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Concord
country: United States
facility: Pfizer Investigational Site
state: California
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Stockton
country: United States
facility: Pfizer Investigational Site
state: California
city: Thouasand Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Westlake Village
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Coral Gables
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Pierce
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jupiter
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Bay
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sebastian
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Wellington
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Creve Coevr
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Erlanger
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Slidell
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Elkton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: Lake Success
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Monroe
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Elyria
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Olmsted Township
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Beaverton
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Hillsboro
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: The Colony
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Newport News
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Oregon
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Dottignies
country: Belgium
facility: Pfizer Investigational Site
city: Ham
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Hoeilaart
country: Belgium
facility: Pfizer Investigational Site
city: La Louviere
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Wilsele
country: Belgium
facility: Pfizer Investigational Site
city: Beckum
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Feldafing
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Homburg/Saar
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Kuenzing
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Offenbach
country: Germany
facility: Pfizer Investigational Site
city: Rodgau
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Suwon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Tlalpan
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: Bekkestua
country: Norway
facility: Pfizer Investigational Site
city: Elverum
country: Norway
facility: Pfizer Investigational Site
city: Honefoss
country: Norway
facility: Pfizer Investigational Site
city: Jessheim
country: Norway
facility: Pfizer Investigational Site
city: Kongsberg
country: Norway
facility: Pfizer Investigational Site
city: Lena
country: Norway
facility: Pfizer Investigational Site
city: Lierskogen
country: Norway
facility: Pfizer Investigational Site
city: Molde
country: Norway
facility: Pfizer Investigational Site
city: Moss
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Roverud
country: Norway
facility: Pfizer Investigational Site
city: Skedsmokorset
country: Norway
facility: Pfizer Investigational Site
city: Tromso
country: Norway
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Jarfalla
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Strangnas
country: Sweden
facility: Pfizer Investigational Site
city: Umea
country: Sweden
facility: Pfizer Investigational Site
city: Penzance
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Woolwell, Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Middlesex
country: United Kingdom
facility: Pfizer Investigational Site
state: Harrow
city: Garston
country: United Kingdom
facility: Pfizer Investigational Site
state: Hertfordshire
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancs. Fy3 7dq
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: East Horsley, Leatherhead
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Warminster
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: