|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01287182 |
|
Date of registration:
|
29/01/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
|
|
Scientific title:
|
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis |
|
Date of first enrolment:
|
May 2011 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01287182 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Lebanon
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Atherosclerosis
|
|
Intervention(s)
|
|
Drug: Ateronon
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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]
|
|
Secondary ID(s)
|
|
OP2912011
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|