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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014