CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
Divaza +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03485495
NCT03485495Phase 4Completed

Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Study of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients With Cerebral Atherosclerosis

Materia Medica Holding·interventional·Posted Apr 2, 2018·Updated Aug 26, 2021

In Brief

A Phase 4 clinical trial evaluating Divaza and Placebo for Cerebral Atherosclerosis. Completed, enrolled 124 participants across 10 sites.

Detailed Summary

The purpose of this study is to obtain additional data on efficacy and safety of Divaza for adjustment of oxidative disorders in patients with cerebral atherosclerosis. It is assumed that the inclusion of the drug Divaza in the basic therapy will help reduce the severity of cognitive disorders, other clinical symptoms of cerebral atherosclerosis, reduce the impact of the disease on the quality of life of the patient. Participate in the study may be patients with a diagnosis of "cerebral atherosclerosis", which, against the backdrop of basic therapy with constant doses of drugs (within the last 4 weeks), to achieve a stable course of cerebral atherosclerosis, cognitive disorders without significant disability are detected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 2, 2018
Enrollment StartApr 12, 2018
Primary CompletionApr 11, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.3 years ago

Interventions

Divazadrug

Oral administration.

Placebodrug

Oral administration.