Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)
NCT ID: NCT01279590
Last Updated: 2011-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2011-03-31
2011-11-30
Brief Summary
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To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients previously intolerant to statins.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PPD10558
Dosing will be forced-titrated as follows: 40 mg orally twice daily for 4 weeks and 80 mg orally twice daily for 8 weeks
PPD10558
PPD10558 40 mg capsule and matching placebo capsule twice a day for 4 weeks, then
PPD10558 80 mg (two 40 mg capsules) twice a day for 8 weeks
Atorvastatin
Dosing will be forced titrated as 40 mg orally once daily for 4 weeks, and 80 mg orally once daily for 8 weeks
Atorvastatin
Atorvastatin 40 mg capsule and matching placebo capsule in the morning and 2 placebo capsules in the evening for 4 weeks, then
Atorvastatin 80 mg (two 40 mg capsules) in the morning and 2 placebo capsules in the evening for 8 weeks
Placebo
Dosing will be 2 placebo capsules twice daily for 12 weeks
Placebo
2 placebo capsules twice daily for 12 weeks
Interventions
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PPD10558
PPD10558 40 mg capsule and matching placebo capsule twice a day for 4 weeks, then
PPD10558 80 mg (two 40 mg capsules) twice a day for 8 weeks
Atorvastatin
Atorvastatin 40 mg capsule and matching placebo capsule in the morning and 2 placebo capsules in the evening for 4 weeks, then
Atorvastatin 80 mg (two 40 mg capsules) in the morning and 2 placebo capsules in the evening for 8 weeks
Placebo
2 placebo capsules twice daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* history of statin-associated myalgia, as defined by being unable to tolerate two previous statins due to muscle pain, aches, weakness, or cramping that begins or increases during statin therapy and stops when statin therapy is discontinued. History of statin-associated myalgia will be captured on the historical questionnaire on statin-associated myalgia.
* LDL-C \> 110 mg/dL and triglycerides \< 500 mg/dL at Prescreening.
* prescreening hemoglobin value of ≥10 g/dL for females and ≥12 g/dL.
* patient agrees to stop all other antihyperlipidemic agents (including but not limited to niacin, probucol, ezetimibe, fibrates and derivatives, bile acid-sequestering agents, other 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase inhibitors, fish oils, flaxseed oil, and red yeast rice).
* patient agrees to stop all Coenzyme Q10 supplements.
* if taking other nonexcluded medications, patients must be on a stable dose for 4 weeks before screening.
Exclusion Criteria
* requires the chronic use of pain medications, including acetaminophen, non-steroidal anti-inflammatory medications, narcotics, and other analgesics.
* vitamin D insufficiency (current insufficiency is defined as Vitamin D3 \< 20 ng/mL \[50 nmol/L\] measured at Prescreening.
* hypothyroidism or abnormal thyroid function test as confirmed by thyroid-stimulating hormone ≥ 5 mcIU/mL and free thyroxine (T4) \< 0.7 ng/dL at Prescreening
* history of rhabdomyolysis (defined as evidence of organ damage with creatinine kinase(CK) \> 10,000 IU/L).
* history of liver disease
* history of significant renal dysfunction as defined by serum creatinine clearance \< 30 mL/min
* Nephrotic-range proteinuria.
* HbA1C \>9% at Prescreening.
* CK levels \>5 times the upper limit of normal at Prescreening.
* congestive heart failure, even with current therapy
* has had myocardial infarction, cardiac intervention, cerebrovascular accident/stroke or transient ischemic attack less than 6 months prior to prescreening.
* patient is pregnant (confirmed by laboratory testing) or breastfeeding.
* history of cancer (other than basal cell and/or squamous cell carcinoma of the skin and/or Stage I squamous cell carcinoma of the cervix) that has not been in full remission for at least 1 year before Screening.
* patient has positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus types 1 or 2 at Prescreening.
40 Years
ALL
No
Sponsors
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Furiex Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Furiex research site
Anniston, Alabama, United States
Furiex research site
Phoenix, Arizona, United States
Furiex research site
Phoenix, Arizona, United States
Furiex research site
Huntington Park, California, United States
Furiex research site
Long Beach, California, United States
Furiex research site
Pismo Beach, California, United States
Furiex research site
San Diego, California, United States
Furiex research site
West Lake Village, California, United States
Furiex research site
Colorado Springs, Colorado, United States
Furiex research site
Golden, Colorado, United States
Furiex research site
Hartford, Connecticut, United States
Furiex research site
Boynton Beach, Florida, United States
Furiex research site
Coral Gables, Florida, United States
Furiex research site
Deerfield Beach, Florida, United States
Furiex research site
Fort Lauderdale, Florida, United States
Furiex research site
Gainesville, Florida, United States
Furiex research site
Opa-locka, Florida, United States
Furiex research site
Pembroke, Florida, United States
Furiex research site
Pembroke, Florida, United States
Furiex research site
Sanford, Florida, United States
Furiex research site
West Palm Beach, Florida, United States
Furiex research site
Honolulu, Hawaii, United States
Furiex Research site
Boise, Idaho, United States
Furiex research site
Nampa, Idaho, United States
Furiex research site
Chicago, Illinois, United States
Furiex research site
Mission, Kansas, United States
Furiex research site
Madisonville, Kentucky, United States
Furiex research site
Covington, Louisiana, United States
Furiex research site
Auburn, Maine, United States
Furiex research site
Oxon Hill, Maryland, United States
Furiex research site
Bay City, Michigan, United States
Furiex research site
St Louis, Missouri, United States
Furiex research site
Billings, Montana, United States
Furiex research site
Butte, Montana, United States
Furiex research site
Missoula, Montana, United States
Furiex research site
Omaha, Nebraska, United States
Furiex research site
Great Neck, New York, United States
Furiex research site
Asheville, North Carolina, United States
Furiex research site
Cary, North Carolina, United States
Furiex research site
Charlotte, North Carolina, United States
Furiex research site
Harrisburg, North Carolina, United States
Furiex research site
Hickory, North Carolina, United States
Furiex research site
Hickory, North Carolina, United States
Furiex research site
High Point, North Carolina, United States
Furiex research site
Raleigh, North Carolina, United States
Furiex research site
Raleigh, North Carolina, United States
Furiex research site
Wilmington, North Carolina, United States
Furiex research site
Carlisle, Ohio, United States
Furiex research site
Cincinnati, Ohio, United States
Furiex research site
Columbus, Ohio, United States
Furiex research site
Kettering, Ohio, United States
Furiex research site
Springfield, Ohio, United States
Furiex research site
Altoona, Pennsylvania, United States
Furiex research site
Johnstown, Pennsylvania, United States
Furiex research site
Cumberland, Rhode Island, United States
Furiex research site
East Providence, Rhode Island, United States
Furiex research site
Anderson, South Carolina, United States
Furiex research site
Greenville, South Carolina, United States
Furiex research site
Greer, South Carolina, United States
Furiex research site
Mt. Pleasant, South Carolina, United States
Furiex research site
Pawleys Island, South Carolina, United States
Furiex research site
Bristol, Tennessee, United States
Furiex research site
Tomball, Texas, United States
Furiex research site
Salt Lake City, Utah, United States
Furiex research site
Norfolk, Virginia, United States
Furiex research site
Richmond, Virginia, United States
Furiex
Spokane, Washington, United States
Countries
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Other Identifiers
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PPD10558-010
Identifier Type: -
Identifier Source: org_study_id