NCT00405769

Brief Summary

This study will attempt to further validate a clinical treatment plan to lower LDL values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to improve compliance in group of people who are unable to take traditional medication to lower cholesterol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

November 29, 2006

Last Update Submit

October 30, 2007

Conditions

HyperlipidemiaCoronary Artery Disease

Keywords

statin intolerancehyperlipidemialifestyle changesred yeast rice

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program

    24 weeks

Secondary Outcomes (1)

  • HDL, TG, Total cholesterol, cardiac CRP,

    24 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

placebo control

Drug: placebo

2

ACTIVE COMPARATOR

red yeast rice

Drug: red yeast rice

Interventions

red yeast riceDRUG

600 mg 3 caps bid

2
placeboDRUG

3 caps bid

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Baseline cholesterol - LDL more than 160 with one risk factor or LDL more than 130 with 2 or more risk factors for developing coronary artery disease (Smoker, age \>40, male, Family history, diabetes, obesity) utilizing ATP III guidelines
  • Have had a statin prescribed by a doctor for high cholesterol, and have stopped medication because of side effects
  • Ability to exercise without physical restrictions
  • Ability to attend 12 week consecutive Change of Heart sessions
  • Not taking any cholesterol lowering medication for at least 1 month prior to initiation of trial. Not taking red yeast rice for at least 1 month prior.

You may not qualify if:

  • Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year
  • Known intolerance to one of the study drugs
  • Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease
  • Uncontrolled hypertension (defined as SBP\>180 mmHg or DBP \> 100mmHg.
  • Heart attack, bypass surgery, or angioplasty/stent within 1 year of study
  • Triglyceride level more than 400 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Hill Hospital

Philadelphia, Pennsylvania, 19118, United States

Location

Related Publications (1)

  • Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):830-9, W147-9. doi: 10.7326/0003-4819-150-12-200906160-00006.

    PMID: 19528562DERIVED

MeSH Terms

Conditions

HyperlipidemiasCoronary Artery Disease

Interventions

red yeast rice

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • David J Becker, MD

    Chestnut Hill Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2006

First Posted

November 30, 2006

Study Start

January 1, 2007

Study Completion

October 1, 2007

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

US(1)