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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omicron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01287182
First received: January 29, 2011
Last updated: May 18, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.


Condition Intervention Phase
Atherosclerosis
 Drug: Ateronon
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Omicron Pharmaceuticals:

Primary Outcome Measures:
  • to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Active Comparator: Ateronon Drug: Ateronon
Ateronon daily for 3 months

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287182

Locations
Lebanon
Rafic Hariri University Hospital
Beirut, Bir Hasan, Lebanon
Sponsors and Collaborators
Omicron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Omicron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01287182     History of Changes
Other Study ID Numbers: OP2912011
Study First Received: January 29, 2011
Last Updated: May 18, 2013
Health Authority: United States: Food and Drug Administration
Lebanon: Institutional Review Board

Keywords provided by Omicron Pharmaceuticals:
Asymptomatic Myocardial Ischemic patients

Additional relevant MeSH terms:
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on June 17, 2013