drugset
drugset / Trial / NCT01279590

Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)

NCT01279590 ↗

Phase 2 Completed 282 enrolled Furiex Pharmaceuticals, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2011-03
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 80 mg Oral
Subject BEMFIVASTATIN Small molecule 80 mg Oral

Indications

hyperlipidemia