Clinical Trial of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients… (NCT03485495) | Clinical Trial Compass
CompletedPhase 4
Clinical Trial of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients With Cerebral Atherosclerosis
Russia124 participantsStarted 2018-04-12
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients of both genders aged 40-75 years old inclusive.
✓. Diagnosis of cerebral atherosclerosis verified by all three signs:
✓. Cognitive disorders (MoCa \<26).
✓. Patients with unchanged dose and combination of basic therapy of cerebral atherosclerosis and hypertension during the previous month.
✓. Patients who gave their consent to use reliable contraception during the study.
✓. Availability of signed patient information sheet and informed consent form for participation in the clinical trial.
Exclusion criteria
✕. History of subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral tumour or another disease resulting in neurological disorders.
✕. Ischemic-type stroke or any other acute cerebrovascular accident less than 6 months prior to the study with Modified Rankin Scale (mRs) \> 1 .
✕. Cardiac sources of high risk or medium risk embolism (TOAST criteria).
What they're measuring
1
Change in Mean Value of Lipoprotein Resistance to LPO.