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Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

NCT00639223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2010-01-18

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Red Yeast Rice

Four 600mg capsules twice daily for 12 weeks

DRUG

Pravastatin

One 20mg capsule twice daily for 12 weeks

BEHAVIORAL

Lifestyle modification program

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

Sponsors & Collaborators

Principal Investigators

  • Steven C Halbert, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-07-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639223 on ClinicalTrials.gov