A Double-blind, Randomized, Placebo-controlled and Active-comparator-controlled Phase 2b Study to Evaluate Statin-associated Myalgia Incidence, Lipid Profile Effect, and Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients With Primary Hypercholesterolemia, Fredrickson IIa or IIb, Who Have Discontinued Two or More Prior Statin Therapies Due to Statin-associated Myalgia
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Incidence of stopping treatment with double-blinded study drug due to statin-associated myalgia.
Patients who withdraw from participating in the study prior to Week 12 and who also stop study drug due to SAM, or patients who become lost to follow up will be considered to have stopped treatment with double-blinded study drug.
Up to week 12
No
United States: Food and Drug Administration
PPD10558-010
NCT01279590
March 2011
November 2011
Name | Location |
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Furiex research site | Anniston, Alabama 36207 |
Furiex research site | Phoenix, Arizona 85018 |
Furiex research site | Huntington Park, California 90255 |
Furiex research site | Colorado Springs, Colorado 80907 |
Furiex research site | Hartford, Connecticut 06102 |
Furiex research site | Boynton Beach, Florida 33472 |
Furiex research site | Honolulu, Hawaii 96814 |
Furiex Research site | Boise, Idaho 83704 |
Furiex research site | Chicago, Illinois 60616 |
Furiex research site | Mission, Kansas 66202 |
Furiex research site | Madisonville, Kentucky 42431 |
Furiex research site | Covington, Louisiana 70433 |
Furiex research site | Auburn, Maine 04210 |
Furiex research site | Oxon Hill, Maryland 20745 |
Furiex research site | Bay City, Michigan 48706 |
Furiex research site | St. Louis, Missouri 63117 |
Furiex research site | Billings, Montana 59101 |
Furiex research site | Omaha, Nebraska 68144 |
Furiex research site | Great Neck, New York 11023 |
Furiex research site | Asheville, North Carolina 28803 |
Furiex research site | Carlisle, Ohio 45005 |
Furiex research site | Altoona, Pennsylvania 16602 |
Furiex research site | Cumberland, Rhode Island 02864 |
Furiex research site | Anderson, South Carolina 29621 |
Furiex research site | Bristol, Tennessee 37620 |
Furiex research site | Tomball, Texas 77375 |
Furiex research site | Salt Lake City, Utah 84124 |
Furiex research site | Norfolk, Virginia 23502 |
Furiex | Spokane, Washington 99208 |