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NCT01287182 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01287182
Other study ID # OP2912011
Secondary ID
Status Completed
Phase Phase 3
First received January 29, 2011
Last updated May 18, 2013
Start date May 2011
Est. completion date December 2011

Study information
Verified date May 2013
Source Omicron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationLebanon: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ateronon
Ateronon daily for 3 months

Locations
Country Name City State
Lebanon Rafic Hariri University Hospital Beirut Bir Hasan

Sponsors (1)
Lead Sponsor Collaborator
Omicron Pharmaceuticals

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease Baseline and 3 months Yes
Secondary 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 Yes
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