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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Omicron Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Omicron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01287182
First received: January 29, 2011
Last updated: May 13, 2011
Last verified: May 2011
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
 Dietary Supplement: Ateronon
Behavioral: Life Style modifications
 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 ]

Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Behavioral: Life Style modifications
Life Style modification
Active Comparator: Ateronon Dietary Supplement: Ateronon
7 mg 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

Contacts
Contact: Dr. Samer Kabbani, M.D. +9613735292
Contact: Sanan Sdepanian +9617098618 sana_sdepanian@yahoo.com

Locations
Lebanon
Rafic Hariri University Hospital Recruiting
Beirut, Bir Hasan, Lebanon
Contact: Dr. Samer Kabbani, M.D.            
Principal Investigator: Dr. Samer Kabbani, M.D.            
Principal Investigator: Dr.Akram Echtay, M.D            
Sponsors and Collaborators
Omicron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Dr Samer Kabbani, Omicron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01287182     History of Changes
Other Study ID Numbers: OP2912011
Study First Received: January 29, 2011
Last Updated: May 13, 2011
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 May 19, 2013