- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138762
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol
February 15, 2012 updated by: Pfizer
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).
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For additional information please call: 1-800-718-1021
Study Type
Interventional
Enrollment
3800
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles, Belgium
- Pfizer Investigational Site
-
Dottignies, Belgium
- Pfizer Investigational Site
-
Ham, Belgium
- Pfizer Investigational Site
-
Hasselt, Belgium
- Pfizer Investigational Site
-
Hoeilaart, Belgium
- Pfizer Investigational Site
-
La Louviere, Belgium
- Pfizer Investigational Site
-
Leuven, Belgium
- Pfizer Investigational Site
-
Wilsele, Belgium
- Pfizer Investigational Site
-
-
-
-
-
Beckum, Germany
- Pfizer Investigational Site
-
Berlin, Germany
- Pfizer Investigational Site
-
Bochum, Germany
- Pfizer Investigational Site
-
Erlangen, Germany
- Pfizer Investigational Site
-
Essen, Germany
- Pfizer Investigational Site
-
Feldafing, Germany
- Pfizer Investigational Site
-
Hamburg, Germany
- Pfizer Investigational Site
-
Heidelberg, Germany
- Pfizer Investigational Site
-
Homburg/Saar, Germany
- Pfizer Investigational Site
-
Karlsruhe, Germany
- Pfizer Investigational Site
-
Kuenzing, Germany
- Pfizer Investigational Site
-
Nuernberg, Germany
- Pfizer Investigational Site
-
Offenbach, Germany
- Pfizer Investigational Site
-
Rodgau, Germany
- Pfizer Investigational Site
-
Schwerin, Germany
- Pfizer Investigational Site
-
-
-
-
-
Seoul, Korea, Republic of
- Pfizer Investigational Site
-
Suwon, Korea, Republic of
- Pfizer Investigational Site
-
-
-
-
-
Puebla, Mexico
- Pfizer Investigational Site
-
-
D.f.
-
Mexico, D.f., Mexico
- Pfizer Investigational Site
-
Tlalpan, D.f., Mexico
- Pfizer Investigational Site
-
-
DF
-
Mexico, DF, Mexico
- Pfizer Investigational Site
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico
- Pfizer Investigational Site
-
-
-
-
-
Bekkestua, Norway
- Pfizer Investigational Site
-
Elverum, Norway
- Pfizer Investigational Site
-
Honefoss, Norway
- Pfizer Investigational Site
-
Jessheim, Norway
- Pfizer Investigational Site
-
Kongsberg, Norway
- Pfizer Investigational Site
-
Lena, Norway
- Pfizer Investigational Site
-
Lierskogen, Norway
- Pfizer Investigational Site
-
Molde, Norway
- Pfizer Investigational Site
-
Moss, Norway
- Pfizer Investigational Site
-
Oslo, Norway
- Pfizer Investigational Site
-
Roverud, Norway
- Pfizer Investigational Site
-
Skedsmokorset, Norway
- Pfizer Investigational Site
-
Tromso, Norway
- Pfizer Investigational Site
-
-
-
-
-
Goteborg, Sweden
- Pfizer Investigational Site
-
Jarfalla, Sweden
- Pfizer Investigational Site
-
Linkoping, Sweden
- Pfizer Investigational Site
-
Orebro, Sweden
- Pfizer Investigational Site
-
Strangnas, Sweden
- Pfizer Investigational Site
-
Umea, Sweden
- Pfizer Investigational Site
-
-
-
-
Cornwall
-
Penzance, Cornwall, United Kingdom
- Pfizer Investigational Site
-
-
Devon
-
Woolwell, Plymouth, Devon, United Kingdom
- Pfizer Investigational Site
-
-
Harrow
-
Middlesex, Harrow, United Kingdom
- Pfizer Investigational Site
-
-
Hertfordshire
-
Garston, Hertfordshire, United Kingdom
- Pfizer Investigational Site
-
-
Lancashire
-
Blackpool, Lancashire, United Kingdom
- Pfizer Investigational Site
-
-
Lancs. Fy3 7dq
-
Blackpool, Lancs. Fy3 7dq, United Kingdom
- Pfizer Investigational Site
-
-
Surrey
-
Addlestone, Surrey, United Kingdom
- Pfizer Investigational Site
-
East Horsley, Leatherhead, Surrey, United Kingdom
- Pfizer Investigational Site
-
-
Wiltshire
-
Warminster, Wiltshire, United Kingdom
- Pfizer Investigational Site
-
-
-
-
Alabama
-
Mobile, Alabama, United States
- Pfizer Investigational Site
-
-
Arizona
-
Mesa, Arizona, United States
- Pfizer Investigational Site
-
Oro Valley, Arizona, United States
- Pfizer Investigational Site
-
Phoenix, Arizona, United States
- Pfizer Investigational Site
-
Sun City, Arizona, United States
- Pfizer Investigational Site
-
-
Arkansas
-
Little Rock, Arkansas, United States
- Pfizer Investigational Site
-
-
California
-
Anaheim, California, United States
- Pfizer Investigational Site
-
Carmichael, California, United States
- Pfizer Investigational Site
-
Concord, California, United States
- Pfizer Investigational Site
-
Greenbrae, California, United States
- Pfizer Investigational Site
-
Los Angeles, California, United States
- Pfizer Investigational Site
-
Mission Viejo, California, United States
- Pfizer Investigational Site
-
Sacramento, California, United States
- Pfizer Investigational Site
-
Santa Ana, California, United States
- Pfizer Investigational Site
-
Stockton, California, United States
- Pfizer Investigational Site
-
Thouasand Oaks, California, United States
- Pfizer Investigational Site
-
Tustin, California, United States
- Pfizer Investigational Site
-
Upland, California, United States
- Pfizer Investigational Site
-
Walnut Creek, California, United States
- Pfizer Investigational Site
-
Westlake Village, California, United States
- Pfizer Investigational Site
-
-
Colorado
-
Boulder, Colorado, United States
- Pfizer Investigational Site
-
-
Connecticut
-
Waterbury, Connecticut, United States
- Pfizer Investigational Site
-
-
Delaware
-
Newark, Delaware, United States
- Pfizer Investigational Site
-
-
Florida
-
Coral Gables, Florida, United States
- Pfizer Investigational Site
-
Ft. Pierce, Florida, United States
- Pfizer Investigational Site
-
Jacksonville, Florida, United States
- Pfizer Investigational Site
-
Jupiter, Florida, United States
- Pfizer Investigational Site
-
Lake Worth, Florida, United States
- Pfizer Investigational Site
-
Melbourne, Florida, United States
- Pfizer Investigational Site
-
Palm Bay, Florida, United States
- Pfizer Investigational Site
-
Sebastian, Florida, United States
- Pfizer Investigational Site
-
Stuart, Florida, United States
- Pfizer Investigational Site
-
Vero Beach, Florida, United States
- Pfizer Investigational Site
-
Wellington, Florida, United States
- Pfizer Investigational Site
-
West Palm Beach, Florida, United States
- Pfizer Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States
- Pfizer Investigational Site
-
Creve Coevr, Illinois, United States
- Pfizer Investigational Site
-
Peoria, Illinois, United States
- Pfizer Investigational Site
-
Rockford, Illinois, United States
- Pfizer Investigational Site
-
-
Iowa
-
Iowa City, Iowa, United States
- Pfizer Investigational Site
-
-
Kansas
-
Kansas City, Kansas, United States
- Pfizer Investigational Site
-
Overland Park, Kansas, United States
- Pfizer Investigational Site
-
Wichita, Kansas, United States
- Pfizer Investigational Site
-
-
Kentucky
-
Erlanger, Kentucky, United States
- Pfizer Investigational Site
-
Louisville, Kentucky, United States
- Pfizer Investigational Site
-
-
Louisiana
-
Covington, Louisiana, United States
- Pfizer Investigational Site
-
Slidell, Louisiana, United States
- Pfizer Investigational Site
-
-
Maine
-
Scarborough, Maine, United States
- Pfizer Investigational Site
-
-
Maryland
-
Baltimore, Maryland, United States
- Pfizer Investigational Site
-
Bethesda, Maryland, United States
- Pfizer Investigational Site
-
Elkton, Maryland, United States
- Pfizer Investigational Site
-
-
Mississippi
-
Jackson, Mississippi, United States
- Pfizer Investigational Site
-
-
Missouri
-
Jefferson City, Missouri, United States
- Pfizer Investigational Site
-
Kansas City, Missouri, United States
- Pfizer Investigational Site
-
-
Montana
-
Billings, Montana, United States
- Pfizer Investigational Site
-
-
Nebraska
-
Lincoln, Nebraska, United States
- Pfizer Investigational Site
-
Omaha, Nebraska, United States
- Pfizer Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, United States
- Pfizer Investigational Site
-
-
New York
-
Endwell, New York, United States
- Pfizer Investigational Site
-
Lake Success, New York, United States
- Pfizer Investigational Site
-
Rochester, New York, United States
- Pfizer Investigational Site
-
Williamsville, New York, United States
- Pfizer Investigational Site
-
-
North Carolina
-
Charlotte, North Carolina, United States
- Pfizer Investigational Site
-
Concord, North Carolina, United States
- Pfizer Investigational Site
-
Fayetteville, North Carolina, United States
- Pfizer Investigational Site
-
Monroe, North Carolina, United States
- Pfizer Investigational Site
-
Raleigh, North Carolina, United States
- Pfizer Investigational Site
-
Winston-Salem, North Carolina, United States
- Pfizer Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, United States
- Pfizer Investigational Site
-
Elyria, Ohio, United States
- Pfizer Investigational Site
-
Olmsted Township, Ohio, United States
- Pfizer Investigational Site
-
Westlake, Ohio, United States
- Pfizer Investigational Site
-
-
Oklahoma
-
Tulsa, Oklahoma, United States
- Pfizer Investigational Site
-
-
Oregon
-
Beaverton, Oregon, United States
- Pfizer Investigational Site
-
Hillsboro, Oregon, United States
- Pfizer Investigational Site
-
Portland, Oregon, United States
- Pfizer Investigational Site
-
-
Rhode Island
-
Warwick, Rhode Island, United States
- Pfizer Investigational Site
-
-
South Carolina
-
Greer, South Carolina, United States
- Pfizer Investigational Site
-
Spartanburg, South Carolina, United States
- Pfizer Investigational Site
-
-
Tennessee
-
Kingsport, Tennessee, United States
- Pfizer Investigational Site
-
Nashville, Tennessee, United States
- Pfizer Investigational Site
-
-
Texas
-
Austin, Texas, United States
- Pfizer Investigational Site
-
Beaumont, Texas, United States
- Pfizer Investigational Site
-
Bryan, Texas, United States
- Pfizer Investigational Site
-
Dallas, Texas, United States
- Pfizer Investigational Site
-
Houston, Texas, United States
- Pfizer Investigational Site
-
San Antonio, Texas, United States
- Pfizer Investigational Site
-
The Colony, Texas, United States
- Pfizer Investigational Site
-
-
Utah
-
Salt Lake City, Utah, United States
- Pfizer Investigational Site
-
-
Virginia
-
Newport News, Virginia, United States
- Pfizer Investigational Site
-
Norfolk, Virginia, United States
- Pfizer Investigational Site
-
Richmond, Virginia, United States
- Pfizer Investigational Site
-
-
Washington
-
Renton, Washington, United States
- Pfizer Investigational Site
-
Yakima, Washington, United States
- Pfizer Investigational Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States
- Pfizer Investigational Site
-
Oregon, Wisconsin, United States
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
LDL and HDL levels
|
Secondary Outcome Measures
Outcome Measure |
---|
other lipid parameters
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 26, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Estimate)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 15, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5091018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperlipidemia
-
Drug Commission of the German Medical AssociationMadaus AGTerminatedHypercholesterolemia | Combined Hyperlipidemia
-
Misr University for Science and TechnologyActive, not recruiting
-
DongKoo Bio & PharmaUnknownHyperlipidemia, HypertriglyceridemiaKorea, Republic of
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHypercholesterolemia and HyperlipidemiaChina
-
Jeil Pharmaceutical Co., Ltd.CompletedHypertension With HyperlipidemiaKorea, Republic of
-
PfizerWithdrawnPrimary Hyperlipidemia or Mixed DyslipidemiaChina
-
ShionogiIntegriumCompletedCombined HyperlipidemiaUnited States
-
Boryung Pharmaceutical Co., LtdCompletedHypertension, HyperlipidemiaKorea, Republic of
-
Boryung Pharmaceutical Co., LtdCompletedHypertension, Hyperlipidemia
-
IlDong Pharmaceutical Co LtdCompletedHypertension With HyperlipidemiaKorea, Republic of
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States