NCT00365742

Brief Summary

Randomized trial in a primary prevention population

  • all participants have high LDL cholesterol Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

August 17, 2006

Status Verified

August 1, 2006

First QC Date

August 16, 2006

Last Update Submit

August 16, 2006

Conditions

Hyperlipidemia

Keywords

red yeast ricepharmaceutical grade fish oilsimvastatinprimary prevention

Outcome Measures

Primary Outcomes (1)

  • LDL-c cholesterol

Secondary Outcomes (4)

  • total cholesterol

  • HDL

  • Triglycerides

  • cardiac CRP

Interventions

simvastatinDRUG
red yeast riceDRUG
pharmaceutical grade fish oilDRUG
therapeutic lifestyle changesBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study

You may not qualify if:

  • No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP\>190 or DBP\>100), cannot have known intolerance to one of the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Simvastatinred yeast rice

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • David Becker

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

April 1, 2006

Study Completion

June 1, 2006

Last Updated

August 17, 2006

Record last verified: 2006-08