A Phase 2 interventional study of PPD10558 and Atorvastatin in Myalgia, Hypercholesterolemia and Hyperlipidemia, sponsored by Furiex Pharmaceuticals, Inc. Completed at 67 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-12-22.
Sponsored by Furiex Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment
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.
282 studies on the registry are indexed under Myalgia; 43 are open to participants now.
This study's enrollment of 282 is above the median of 44 across 241 interventional studies indexed under Myalgia.
Browse Myalgia studies →Furiex Pharmaceuticals, Inc is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dosing will be forced-titrated as follows: 40 mg orally twice daily for 4 weeks and 80 mg orally twice daily for 8 weeks
Drug: PPD10558
Dosing will be forced titrated as 40 mg orally once daily for 4 weeks, and 80 mg orally once daily for 8 weeks
Drug: Atorvastatin
Dosing will be 2 placebo capsules twice daily for 12 weeks
Drug: Placebo
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 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
2 placebo capsules twice daily for 12 weeks
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.
Time frame: Up to week 12
Change from Baseline in fasting lipid profile components (low density lipoprotein-cholesterol(LDL-C), high density lipoprotein-cholesterol(HDL-C), triglyceride(TG), total cholesterol(TC), Apolipoprotein B(ApoB), HDL-TG, LDL/HDL ratio and TC/HDL ratio)
Time frame: Up to week 12
Change from baseline in muscle strength measurements (Sit-to-stand(STS) performance and hand grip strength by Jamar Hydraulic Hand Dynamometer)
Time frame: Up to week 12
Frequency of pain rescue medication
Time frame: Up to week 12
Change from Baseline in inflammatory markers (Tumor necrosis factor α (TNF-α), C-reactive protein (CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2))
Time frame: Up to week 12
Change in patients' functional health and well-being as measured by the Short Form-36v2 Health Survey (SF-36)
Time frame: Up to week 12
Time to onset of statin -associated myalgia (SAM)
Time frame: Up to week 12
Time to stopping treatment with study drug due to SAM
Time frame: Up to week 12
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Furiex Pharmaceuticals, Inc