Back to resultsTrial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Lebanon
Study Type
Interventional
Intervention
Ateronon
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Asymptomatic Myocardial Ischemic patients
Eligibility 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
Sites / Locations
- Rafic Hariri University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Ateronon
Arm Description
Outcomes
Primary Outcome Measures
to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01287182
Brief Title
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Official Title
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omicron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Asymptomatic Myocardial Ischemic patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Ateronon
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ateronon
Intervention Description
Ateronon daily for 3 months
Primary Outcome Measure Information:
Title
to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Rafic Hariri University Hospital
City
Beirut
State/Province
Bir Hasan
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
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