Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)
Completed · Phase 2 · Has a placebo group
Conditions studied: Myalgia, Hypercholesterolemia, Hyperlipidemia
In brief
The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins. To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients previously intolerant to statins.
Key facts
- Study ID
- NCT01279590
- Run by
- Furiex Pharmaceuticals, Inc
- People needed
- 282
- Starts
- 2011-03-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2011-12-22
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of primary hypercholesterolemia (heterozygous familial and nonfamilial) Fredrickson types IIa or IIb.
- 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.
You may not qualify if…
- history of chronic pain and currently experiences chronic pain unrelated to statins that requires chronic use of pain medications, has been diagnosed with fibromyalgia or has severe neuropathic pain.
- 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.
Where it is running
- 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 — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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