Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
NCT ID: NCT01742000
Last Updated: 2012-12-06
Study Results
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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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2007-01-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Karinat
Karinat 500 mg tablet by mouth three times a day
Karinat
Sugar pill
Placebo 500 mg tablet by mouth three times a day
Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet
Interventions
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Karinat
Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet
Eligibility Criteria
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Inclusion Criteria
* Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
* The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
* The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
* The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion
Exclusion Criteria
* Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)
* Personal history or diagnostic of following diseases:
1. Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
2. Pulmonary thromboembolism
3. Chronic heart failure IIa-III
4. Uncontrolled arterial hypertension (systolic blood pressure \> 145 mmHg, diastolic blood pressure \> 95 mmHg under hypotensive therapy)
5. Malignancy
6. Chronic renal failure II-III
7. Chronic hepatic failure II-III
8. Liver cirrhosis
9. Individual intolerance of Karinat or major side effects
FEMALE
Yes
Sponsors
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Institute for Atherosclerosis Research, Russia
OTHER
Responsible Party
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Other Identifiers
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IAR-KT-POST
Identifier Type: -
Identifier Source: org_study_id