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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00134264
Other study ID # A5091043
Secondary ID
Status Terminated
Phase Phase 3
First received August 22, 2005
Last updated January 30, 2012
Start date July 2004
Est. completion date June 2007

Study information

Verified date January 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents


Recruitment information / eligibility

Status Terminated
Enrollment 15067
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

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 evaluationof response, or render unlikely that the subject would complete the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
torcetrapib/atorvastatin

atorvastatin


Locations

Country Name City State
Australia Pfizer Investigational Site Adelaide South Australia
Australia Pfizer Investigational Site Bedford Park South Australia
Australia Pfizer Investigational Site Camperdown
Australia Pfizer Investigational Site Chermside Queensland
Australia Pfizer Investigational Site Clayton Victoria
Australia Pfizer Investigational Site Concord New South Wales
Australia Pfizer Investigational Site Darlinghurst
Australia Pfizer Investigational Site East Gosford New South Wales
Australia Pfizer Investigational Site Fitzroy Victoria
Australia Pfizer Investigational Site Footscray Victoria
Australia Pfizer Investigational Site Fremantle Western Australia
Australia Pfizer Investigational Site Geelong
Australia Pfizer Investigational Site Heidelberg Victoria
Australia Pfizer Investigational Site Herston Queensland
Australia Pfizer Investigational Site Joondalup Western Australia
Australia Pfizer Investigational Site Launceston, Tas
Australia Pfizer Investigational Site Melbourne
Australia Pfizer Investigational Site Nedlands
Australia Pfizer Investigational Site Perth
Australia Pfizer Investigational Site Prahran Victoria
Australia Pfizer Investigational Site Southport
Australia Pfizer Investigational Site St. Leonards New South Wales
Australia Pfizer Investigational Site Wollongong New South Wales
Australia Pfizer Investigational Site Woodville South Australia
Australia Pfizer Investigational Site Woolloongabba Queensland
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Cornwall Ontario
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Laval Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Newmarket Ontario
Canada Pfizer Investigational Site Oshawa Ontario
Canada Pfizer Investigational Site Saint John's
Canada Pfizer Investigational Site Sainte-foy Quebec
Canada Pfizer Investigational Site Sarnia Ontario
Canada Pfizer Investigational Site Scarborough Ontario
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site Ste-foy Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Winnipeg Manitoba
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site AN Rotterdam
Netherlands Pfizer Investigational Site Apeldoorn
Netherlands Pfizer Investigational Site Arnhem
Netherlands Pfizer Investigational Site Breda
Netherlands Pfizer Investigational Site Cappelle aan den IJssel
Netherlands Pfizer Investigational Site Delft
Netherlands Pfizer Investigational Site Eindhoven
Netherlands Pfizer Investigational Site Goes
Netherlands Pfizer Investigational Site Gouda
Netherlands Pfizer Investigational Site Groningen
Netherlands Pfizer Investigational Site Heerlen
Netherlands Pfizer Investigational Site Hertogenbosch
Netherlands Pfizer Investigational Site Hoorn
Netherlands Pfizer Investigational Site Leiden
Netherlands Pfizer Investigational Site Maastricht
Netherlands Pfizer Investigational Site Nijmegen
Netherlands Pfizer Investigational Site Rotterdam
Netherlands Pfizer Investigational Site Sittard
Netherlands Pfizer Investigational Site Utrecht
Netherlands Pfizer Investigational Site Velp
Netherlands Pfizer Investigational Site Venlo
Netherlands Pfizer Investigational Site Zoetermeer
Spain Pfizer Investigational Site Almeria
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Ciudad Real
Spain Pfizer Investigational Site Ferrol La Coruna
Spain Pfizer Investigational Site Granada
Spain Pfizer Investigational Site Jerez de La Frontera Cadiz
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Malaga
Spain Pfizer Investigational Site Salamanca
Spain Pfizer Investigational Site San Sebastian Guipuzcoa
Spain Pfizer Investigational Site Sant Coloma de Gramenet Barcelona
Spain Pfizer Investigational Site Santander Cantabria
Spain Pfizer Investigational Site Santiago De Compostela La Coruña
Spain Pfizer Investigational Site Sevilla
Spain Pfizer Investigational Site Terrasa Barcelona
Spain Pfizer Investigational Site Valencia
Spain Pfizer Investigational Site Zaragoza
Sweden Pfizer Investigational Site Borås
Sweden Pfizer Investigational Site Eskilstuna
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Göteborg
Sweden Pfizer Investigational Site Hässleholm
Sweden Pfizer Investigational Site Helsingborg
Sweden Pfizer Investigational Site Karlshamn
Sweden Pfizer Investigational Site Koping
Sweden Pfizer Investigational Site Linköping
Sweden Pfizer Investigational Site Lulea
Sweden Pfizer Investigational Site Lund
Sweden Pfizer Investigational Site Malmo
Sweden Pfizer Investigational Site Molndal
Sweden Pfizer Investigational Site Norrkoping
Sweden Pfizer Investigational Site Ostersund
Sweden Pfizer Investigational Site Skelleftea
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uddevalla
Sweden Pfizer Investigational Site Uppsala
Sweden Pfizer Investigational Site Västervik
Sweden Pfizer Investigational Site Vaxjo
United Kingdom Pfizer Investigational Site Aberdeen
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Bournemouth
United Kingdom Pfizer Investigational Site Brighton, East Sussex
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Cardiff
United Kingdom Pfizer Investigational Site Chichester
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site Dundee
United Kingdom Pfizer Investigational Site Edinburgh
United Kingdom Pfizer Investigational Site Exeter
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Glasgow Scotland
United Kingdom Pfizer Investigational Site Harrow
United Kingdom Pfizer Investigational Site Leicester
United Kingdom Pfizer Investigational Site Liverpool
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Newcastle-upon-Tyne
United Kingdom Pfizer Investigational Site Romford
United Kingdom Pfizer Investigational Site Shrewsbury
United Kingdom Pfizer Investigational Site Warwick
United Kingdom Pfizer Investigational Site Woolwich London
United Kingdom Pfizer Investigational Site Wrexham Clwyd
United States Pfizer Investigational Site Abington Massachusetts
United States Pfizer Investigational Site Alabaster Alabama
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Aurora Illinois
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baton Rouge Louisiana
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Beaver Pennsylvania
United States Pfizer Investigational Site Bel Air Maryland
United States Pfizer Investigational Site Billings Montana
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Blue Island Illinois
United States Pfizer Investigational Site Burien Washington
United States Pfizer Investigational Site Burlington Vermont
United States Pfizer Investigational Site Butte Montana
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbia Maryland
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Concord New Hampshire
United States Pfizer Investigational Site Coral Gables Florida
United States Pfizer Investigational Site Covington Louisiana
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Davenport Iowa
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site des Moines Iowa
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Elmer New Jersey
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Fort Meyers Florida
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Garden City New York
United States Pfizer Investigational Site Gilbert Arizona
United States Pfizer Investigational Site Grand Rapids Michigan
United States Pfizer Investigational Site Guilford Connecticut
United States Pfizer Investigational Site Haddon Heights New Jersey
United States Pfizer Investigational Site Hartford Connecticut
United States Pfizer Investigational Site Haverhill Massachusetts
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Beach Florida
United States Pfizer Investigational Site Kingsport Tennessee
United States Pfizer Investigational Site Lakeland Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Longmont Colorado
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Manchester New Hampshire
United States Pfizer Investigational Site Mansfield Ohio
United States Pfizer Investigational Site Marrero Louisiana
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Modesto California
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Natick Massachusetts
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New Hyde Park New York
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Papillon Nebraska
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Plano Texas
United States Pfizer Investigational Site Port Charlotte Florida
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sandusky Ohio
United States Pfizer Investigational Site Santa Rosa California
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Scarborough Maine
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site St. Paul Minnesota
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Towson Maryland
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tustin California
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Westminster Maryland
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Winston-salem North Carolina
United States Pfizer Investigational Site Witchita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The time to first occurrence of a major cardiovascular disease event
Secondary Various composites of major cardiovascular disease events and other lipid parameters
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