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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 29, 2011
Last Updated Date	May 18, 2013
Start Date ^ICMJE	May 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 31, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01287182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 31, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Official Title ^ICMJE	Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Brief Summary	This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Atherosclerosis
Intervention ^ICMJE	Drug: Ateronon Ateronon daily for 3 months
Study Arm (s)	Placebo Comparator: Placebo Active Comparator: Ateronon Intervention: Drug: Ateronon
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	35 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Lebanon

Administrative Information
NCT Number ^ICMJE	NCT01287182
Other Study ID Numbers ^ICMJE	OP2912011
Has Data Monitoring Committee	Yes
Responsible Party	Omicron Pharmaceuticals
Study Sponsor ^ICMJE	Omicron Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Omicron Pharmaceuticals
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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