drugset / Trial / NCT00897975

Red Yeast Rice and Phytosterols In Statin Intolerance

NCT00897975 ↗

Phase 2/3 Completed 200 enrolled Chestnut Hill Health System
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins. The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid lowering benefits when compared to red yeast rice alone. These supplements will be given to all participants. Up to one-half will enroll in a lifestyle intervention program called Change of Heart and will be compared to patients who do not participate in the program. The study will last one year.

Timeline

Start
2009-07
Primary completion
2010-11
Completion
2011-07

Outcome

Missed primary endpoint

paper Phytosterols did not significantly improve LDL-C at weeks 12 (P = .54), 24 (P = .67), or 52 (P = .76) compared with placebo. PMID 23816039 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject phytosterol Unknown 900 mg —

Indications