Who is sponsoring NCT00897975?

NCT00897975 is sponsored by Chestnut Hill Health System.

What condition does NCT00897975 study?

NCT00897975 studies Hyperlipidemia.

What drugs are being tested in NCT00897975?

Interventions: red yeast rice, phytosterol, therapeutic lifestyle program, placebo.

What is the status of NCT00897975?

NCT00897975 is currently COMPLETED.

Last reviewed 2011-07-14 · How we verify

Red Yeast Rice and Phytosterols Versus Red Yeast Rice and Placebo for the Treatment of Hyperlipidemia in Patients With Statin Intolerance: A Multi-Center Randomized Double-blind Study

NCT00897975 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	Chestnut Hill Health System
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	200
Start date	2009-07
Completion	2011-07

Conditions

Hyperlipidemia

Interventions

red yeast rice
phytosterol
therapeutic lifestyle program
placebo

Primary outcomes

LDL cholesterol levels — one year

Countries

United States