Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis

May 18, 2013 updated by: Omicron Pharmaceuticals
This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • Bir Hasan
      • Beirut, Bir Hasan, Lebanon
        • Rafic Hariri University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and Women with demonstrated Coronary Disease
  • AtheroAbzyme positive during screening process
  • Elevated Total Cholesterol
  • Willingness to take study nutritional supplement once a day for 3 months

Exclusion Criteria:

  • Women who are pregnant, nursing or intend pregnancy during the period of treatment
  • Known milk, soy or whey allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Active Comparator: Ateronon
Drug: Ateronon
Ateronon daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease
Time Frame: Baseline and 3 months
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
to evaluate the potential effectiveness of Ateronon in lowering pulse rate as well systolic and diastolic blood pressure in patients with demonstrated coronary disease
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omicron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 29, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

May 18, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP2912011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

Clinical Trials on Ateronon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe