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

NCT ID: NCT01287182

Last Updated: 2013-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Ateronon

Group Type ACTIVE_COMPARATOR

Ateronon

Intervention Type DRUG

Ateronon daily for 3 months

Interventions

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Ateronon

Ateronon daily for 3 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Omicron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rafic Hariri University Hospital

Beirut, Bir Hasan, Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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OP2912011

Identifier Type: -

Identifier Source: org_study_id

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