CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Pravastatin +2 moredrug
Likely dose
Pravastatin 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00639223
NCT00639223Phase 2Completed
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Red Yeast Rice vs. Pravastatin: A Double-Blind Randomized Comparative Study of Myopathic Symptoms

University of Pennsylvania·interventional·Posted Mar 20, 2008·Updated Jan 18, 2010

In Brief

A Phase 2 clinical trial evaluating Red Yeast Rice, Pravastatin, and 1 other intervention for Hypercholesterolemia and Statin-Associated Myopathy. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Statin-Associated Myopathy
CountriesUnited States
CollaboratorsChestnut Hill Health System

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 20, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.3 years ago

Interventions

Red Yeast Ricedietary

Four 600mg capsules twice daily for 12 weeks

Pravastatindrug

One 20mg capsule twice daily for 12 weeks

Lifestyle modification programbehavioral

Weekly sessions each lasting 3 1/2 hours for 12 weeks