Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
1 other identifier
interventional
100
1 country
1
Brief Summary
This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 21, 2013
May 1, 2013
7 months
January 29, 2011
May 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease
Baseline and 3 months
Secondary Outcomes (1)
to evaluate the potential effectiveness of Ateronon in lowering pulse rate as well systolic and diastolic blood pressure in patients with demonstrated coronary disease
Baseline and 3 months
Study Arms (2)
Placebo
PLACEBO COMPARATORAteronon
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women who are pregnant, nursing or intend pregnancy during the period of treatment
- Known milk, soy or whey allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rafic Hariri University Hospital
Beirut, Bir Hasan, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2011
First Posted
February 1, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 21, 2013
Record last verified: 2013-05