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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:
Information provided by (Responsible Party):
Omicron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01287182
First received: January 29, 2011
Last updated: May 18, 2013
Last verified: May 2013

January 29, 2011
May 18, 2013
May 2011
December 2011   (final data collection date for primary outcome measure)
to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01287182 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atherosclerosis
Drug: Ateronon
Ateronon daily for 3 months
  • Placebo Comparator: Placebo
  • Active Comparator: Ateronon
    Intervention: Drug: Ateronon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Lebanon
 
NCT01287182
OP2912011
Yes
Omicron Pharmaceuticals
Omicron Pharmaceuticals
Not Provided
Not Provided
Omicron Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP