Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

NCT00137462 | Completed Phase 3

• 1 other identifier: A5091019
• Study Type: interventional
• Target: 900
• Locations: 2 countries
• Sites: 59

Brief Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.

Secondary Outcomes (1)

• Changes in levels of lipids and other biomarkers.

Interventions

torcetrapib/atorvastatin DRUG

atorvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Statin eligible per NCEP ATP-III guidelines
• At least 18 years of age

You may not qualify if:

• Women who are pregnant or lactating, or planning to become pregnant
• Intolerance to statin therapy
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

Pfizer Investigational Site

Huntsville, Alabama, 35802, United States

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Union Grove, Alabama, 35175, United States

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Fresno, California, 93720, United States

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Los Angeles, California, 90057, United States

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Orange, California, 92868, United States

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San Diego, California, 92128, United States

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Denver, Colorado, 80220, United States

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Denver, Colorado, 80262, United States

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Golden, Colorado, 80401, United States

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Bridgeport, Connecticut, 06610, United States

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Fairfield, Connecticut, 06824, United States

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Trumbull, Connecticut, 06611, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20037, United States

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Boynton Beach, Florida, 33437, United States

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Fort Lauderdale, Florida, 33308, United States

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Gainesville, Florida, 32605, United States

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Gainesville, Florida, 32610, United States

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Gainsville, Florida, 32610, United States

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Sebastian, Florida, 32958, United States

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Vero Beach, Florida, 32960, United States

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Rockford, Illinois, 61108, United States

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Springfield, Illinois, 62704, United States

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Olathe, Kansas, 66061, United States

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Overland Park, Kansas, 66210, United States

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Madisonville, Kentucky, 42431, United States

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Burlington, Massachusetts, 01805, United States

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Grand Rapids, Michigan, 49525, United States

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Troy, Michigan, 48098, United States

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Albuquerque, New Mexico, 87102, United States

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Albuquerque, New Mexico, 87106, United States

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Orchard Park, New York, 14127, United States

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Syracuse, New York, 13202, United States

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Syracuse, New York, 13210, United States

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Williamsville, New York, 14221, United States

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Charlotte, North Carolina, 28262, United States

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Cleveland, Ohio, 44126, United States

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Columbus, Ohio, 43214, United States

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Keizer, Oregon, 97303, United States

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Salem, Oregon, 97302, United States

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Doylestown, Pennsylvania, 18901, United States

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Charleston, South Carolina, 29425, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Mt. Pleasant, South Carolina, 83464, United States

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Kingsport, Tennessee, 37660, United States

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Morristown, Tennessee, 37813, United States

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Dallas, Texas, 75230, United States

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McKinney, Texas, 75069, United States

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Edmonton, Alberta, T6G 2B7, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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London, Ontario, N6C 5J1, Canada

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London, Ontario, N6G 2M3, Canada

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Ottawa, Ontario, K1H 8K7, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Charlottetown, Prince Edward Island, C1A 1L2, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Saint Georges de Beauce, Quebec, G5Y 4W1, Canada

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MeSH Terms

Conditions

Hyperlipidemias

Interventions

torcetrapib; Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: November 1, 2004
• Study Completion: September 1, 2006
• Last Updated: November 16, 2007

Record last verified: 2006-12

Locations

CA (11); US (48)