Hypercholesterolemia Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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