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Trial of Lycopene/Ateronon for Secondary Prevention of Coronary Heart Disease

NCT00939237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2014-08-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether Ateronon, a nutritional supplement that contains lycopene from tomatoes has a favorable effect on carotid atherosclerosis, lipid levels, and other biomarkers of coronary heart disease.

The trial was stopped early due to insufficient financial support from the initial study collaborator, Cambridge Theranostics Ltd. Collected patient data are sufficient for final trial-based analyses to be conducted with financial support from the new study collaborator, CamNutra Ltd. The data will still be analyzed according to the original study aims.

Conditions

Interventions

DRUG

Ateronon

7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily

DRUG

Placebo

Sponsors & Collaborators

  • CamNutra Ltd.

    collaborator INDUSTRY

  • Cambridge Theranostics Ltd

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Howard D. Sesso, ScD, MPH · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00939237 on ClinicalTrials.gov