Status:

COMPLETED

Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders

Lead Sponsor:

Materia Medica Holding

Conditions:

Chronic Cerebral Ischemia

Eligibility:

All Genders

18-90 years

Brief Summary

An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.

Detailed Description

Medical data (demographic and clinical characteristics - diagnosis, MoCA test results) are collected from patients to whom Divaza is prescribed to be taken according to the following regimen: 2 tablet...

Eligibility Criteria

Inclusion

  • Patients of either gender aged 18+ years.
  • Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs.
  • Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month.
  • Signed informed consent form.

Exclusion

  • Other neurological diseases.
  • Any known allergy to/intolerance of any constituent of the medication.
  • Pregnancy, breast-feeding.
  • Participation in other clinical trials for 3 months prior to enrollment in this study.
  • The patient is related to the research personnel of the investigative sites that are directly involved in the study, or is the immediate relative of the investigator, or the employee of OOO NPF Materia Medica Holding.

Key Trial Info

Start Date :

October 1 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2017

Estimated Enrollment :

2583 Patients enrolled

Trial Details

Trial ID

NCT04370028

Start Date

October 1 2016

End Date

January 1 2017

Last Update

March 10 2021

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Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders | DecenTrialz