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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:
ClinicalTrials.gov Identifier:
NCT01287182
First Posted: February 1, 2011
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Omicron Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287182


Locations
Lebanon
Rafic Hariri University Hospital
Beirut, Bir Hasan, Lebanon
Sponsors and Collaborators
Omicron Pharmaceuticals
  More Information

Responsible Party: Omicron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01287182     History of Changes
Other Study ID Numbers: OP2912011
First Submitted: January 29, 2011
First Posted: February 1, 2011
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Omicron Pharmaceuticals:
Asymptomatic Myocardial Ischemic patients

Additional relevant MeSH terms:
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases