Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-13 @ 5:50 PM
Study NCT ID:
NCT03485495
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2018-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients With Cerebral Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000610361', 'term': 'divaza'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PutilovskiyMA@materiamedica.ru', 'phone': '+74952761571', 'title': 'Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director', 'phoneExt': '302', 'organization': 'MATERIA MEDICA HOLDING'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the treatment period - 12 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy and within 24 hours after the last dose of the study drug).', 'eventGroups': [{'id': 'EG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 5, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 3, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Odinophagy', 'notes': 'Sore throat when swallowing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased blood pressure', 'notes': 'Increase in blood pressure to 235/120 mmHg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nosebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthropod bite', 'notes': 'Tick bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Value of Lipoprotein Resistance to LPO.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'classes': [{'title': 'Resistance of LP to LPO at baseline', 'categories': [{'measurements': [{'value': '42.4', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Resistance of LP to LPO after 12 weeks', 'categories': [{'measurements': [{'value': '55.6', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '49.4', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 12 weeks', 'categories': [{'measurements': [{'value': '14.8', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '16.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.', 'groupDescription': 'This analysis applies to ∆ between baseline and after 12 weeks row.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in the mean resistance of lipoprotein (LP) to lipid peroxidation (LPO) after 12-week therapy versus baseline.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in Divaza group had no laboratory data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Improved Cognitive Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0272', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks of the observation period.', 'description': 'MoCA (Montreal Cognitive Assessment) score +1 and over after 12-week therapy versus baseline. Minimum score is 0, maximum score is 30. Higher values represent a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 patients in Divaza group and 2 patients in Placebo group had no data for week 12.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mean Level of Preformed LP Products (Mainly Lipid Hydroperoxides).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'classes': [{'title': 'Level of preformed LPO products at baseline', 'categories': [{'measurements': [{'value': '72.5', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Level of preformed LPO products after 12 weeks', 'categories': [{'measurements': [{'value': '67.7', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '69.9', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 12 weeks', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8762', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 12 weeks row.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks of the observation period', 'description': 'Based on laboratory evaluation. Change in mean level of preformed LP products, predominantly lipid hydroperoxides after 12-week therapy versus baseline.\n\nThe following kinetic parameters of chemiluminescence were measured: rapid chemiluminescence flare amplitude reflecting the stationary level of lipid hydroperoxides.', 'unitOfMeasure': 'Mcmol / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in Divaza group had no laboratory data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mean Value of Lipoprotein Ability for Oxidation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'classes': [{'title': 'LP ability for oxidation at baseline', 'categories': [{'measurements': [{'value': '1027.3', 'spread': '204.7', 'groupId': 'OG000'}, {'value': '993.8', 'spread': '264.1', 'groupId': 'OG001'}]}]}, {'title': 'LP ability for oxidation after 12 weeks', 'categories': [{'measurements': [{'value': '1024.1', 'spread': '226.7', 'groupId': 'OG000'}, {'value': '1040.6', 'spread': '217.7', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 12 weeks', 'categories': [{'measurements': [{'value': '-12.1', 'spread': '192.1', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '241.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2082', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 12 weeks row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in mean value of lipoprotein ability for oxidation after 12-week therapy versus baseline.\n\nFor plasma, draw blood into an EDTA tube and gently invert the tube 8 to 10 times to mix the anticoagulant. Centrifuge the tube, remove the stopper and draw off approximately 2/3 of the upper plasma layer into a labeled transfer tube using a transfer pipet bulb. Plasma must be separated from cells within 45 minutes of venipuncture. Measurement of oxidized LDL (oxLDL) has been incorporated into clinical practice in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, especially as it pertains to the evaluation of oxidative stress. Oxidized LDL-particles are considered to be an important driving factor in the pathophysiology of atherosclerosis and oxLDL measurement has been used to test the efficacy of CVD drugs (eg, statins) to reduce oxidative stress.', 'unitOfMeasure': 'mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in Divaza group had no laboratory data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mean Value of NO Products Serum Concentration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'classes': [{'title': 'NO-3 level at baseline', 'categories': [{'measurements': [{'value': '41.3', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '28.9', 'groupId': 'OG001'}]}]}, {'title': 'NO-3 level (after cuff test) at baseline', 'categories': [{'measurements': [{'value': '38.4', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '79.1', 'spread': '33.5', 'groupId': 'OG001'}]}]}, {'title': 'NO-3 level after 12 weeks', 'categories': [{'measurements': [{'value': '51.7', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '36.8', 'groupId': 'OG001'}]}]}, {'title': 'NO-3 level (after cuff test) after 12 weeks', 'categories': [{'measurements': [{'value': '64.0', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '61.1', 'spread': '27.9', 'groupId': 'OG001'}]}]}, {'title': 'NO-2 level at baseline', 'categories': [{'measurements': [{'value': '35.9', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'NO-2 level (after cuff test) at baseline', 'categories': [{'measurements': [{'value': '31.8', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '69.6', 'spread': '32.3', 'groupId': 'OG001'}]}]}, {'title': 'NO-2 level after 12 weeks', 'categories': [{'measurements': [{'value': '43.9', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'NO-2 level (after cuff test) after 12 weeks', 'categories': [{'measurements': [{'value': '57.0', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '25.9', 'groupId': 'OG001'}]}]}, {'title': 'NO level at baseline', 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'NO level (after cuff test) at baseline', 'categories': [{'measurements': [{'value': '6.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'NO level after 12', 'categories': [{'measurements': [{'value': '7.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'NO level (after cuff test) after 12 weeks', 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment\\*visit" interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'This analysis applies to NO-3 data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment\\*visit" interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'This analysis applies to NO-2 data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment\\*visit" interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'This analysis applies to NO data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in the mean concentration of nitrites and nitrates in serum after 12-week therapy versus baseline. Griess Reaction assay.\n\nIn the Griess reaction, first reported by Johann Peter Griess in 1879 as a method of analysis of nitrite (NO2-), nitrite reacts under acidic conditions with sulfanilic acid (HO3SC6H4NH2) to form a diazonium cation (HO3SC6H4-Ntriple bondN+) which subsequently couples to the aromatic amine 1-naphthylamine (C10H7NH2) to produce a red-violet coloured (λmax ≈ 540 nm), water-soluble azo dye (HO3SC6H4-Ndouble bondN-C10H6NH2).', 'unitOfMeasure': 'μmol per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mean Value of Platelet Aggregation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'classes': [{'title': 'ADP-PA at baseline', 'categories': [{'measurements': [{'value': '46.9', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'ADP-PA (after cuff test) at baseline', 'categories': [{'measurements': [{'value': '45.0', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '51.9', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'ADP-PA after 12 weeks', 'categories': [{'measurements': [{'value': '45.3', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'ADP-PA (after cuff test) after 12 weeks', 'categories': [{'measurements': [{'value': '49.7', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'ADR-PA at baseline', 'categories': [{'measurements': [{'value': '48.4', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'ADR-PA (after cuff test) at baseline', 'categories': [{'measurements': [{'value': '44.7', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'ADR-PA after 12 weeks', 'categories': [{'measurements': [{'value': '47.7', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'ADR-PA (after cuff test) after 12 weeks', 'categories': [{'measurements': [{'value': '54.1', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment\\*visit" interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'This analysis applies to ADP-PA data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment\\*visit" interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'This analysis applies to ADR-PA data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in mean platelet aggregation after 12-week therapy versus baseline.', 'unitOfMeasure': 'percentage aggregation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ADP-AP - platelet aggregation (PA) induced by adenosine diphosphate (ADP) ADR-AP - platelet aggregation (PA) induced by adrenaline (ADR)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Non-compliance with inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nDivaza: Oral administration.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.\n\nPlacebo: Oral administration.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.4', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-05', 'size': 582672, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-29T03:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2018-03-26', 'resultsFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-25', 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Mean Level of Preformed LP Products (Mainly Lipid Hydroperoxides).', 'timeFrame': '12 weeks of the observation period', 'description': 'Based on laboratory evaluation. Change in mean level of preformed LP products, predominantly lipid hydroperoxides after 12-week therapy versus baseline.\n\nThe following kinetic parameters of chemiluminescence were measured: rapid chemiluminescence flare amplitude reflecting the stationary level of lipid hydroperoxides.'}, {'measure': 'Change in Mean Value of Lipoprotein Ability for Oxidation.', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in mean value of lipoprotein ability for oxidation after 12-week therapy versus baseline.\n\nFor plasma, draw blood into an EDTA tube and gently invert the tube 8 to 10 times to mix the anticoagulant. Centrifuge the tube, remove the stopper and draw off approximately 2/3 of the upper plasma layer into a labeled transfer tube using a transfer pipet bulb. Plasma must be separated from cells within 45 minutes of venipuncture. Measurement of oxidized LDL (oxLDL) has been incorporated into clinical practice in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, especially as it pertains to the evaluation of oxidative stress. Oxidized LDL-particles are considered to be an important driving factor in the pathophysiology of atherosclerosis and oxLDL measurement has been used to test the efficacy of CVD drugs (eg, statins) to reduce oxidative stress.'}, {'measure': 'Change in Mean Value of NO Products Serum Concentration.', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in the mean concentration of nitrites and nitrates in serum after 12-week therapy versus baseline. Griess Reaction assay.\n\nIn the Griess reaction, first reported by Johann Peter Griess in 1879 as a method of analysis of nitrite (NO2-), nitrite reacts under acidic conditions with sulfanilic acid (HO3SC6H4NH2) to form a diazonium cation (HO3SC6H4-Ntriple bondN+) which subsequently couples to the aromatic amine 1-naphthylamine (C10H7NH2) to produce a red-violet coloured (λmax ≈ 540 nm), water-soluble azo dye (HO3SC6H4-Ndouble bondN-C10H6NH2).'}, {'measure': 'Change in Mean Value of Platelet Aggregation.', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in mean platelet aggregation after 12-week therapy versus baseline.'}], 'primaryOutcomes': [{'measure': 'Change in Mean Value of Lipoprotein Resistance to LPO.', 'timeFrame': '12 weeks of the observation period.', 'description': 'Based on laboratory evaluation. Change in the mean resistance of lipoprotein (LP) to lipid peroxidation (LPO) after 12-week therapy versus baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Improved Cognitive Function.', 'timeFrame': '12 weeks of the observation period.', 'description': 'MoCA (Montreal Cognitive Assessment) score +1 and over after 12-week therapy versus baseline. Minimum score is 0, maximum score is 30. Higher values represent a better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Atherosclerosis']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.\n\nParticipate 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.', 'detailedDescription': 'Design - a multicenter randomized double-blind placebo-controlled parallel-group clinical trial.\n\nThe study will enroll the patients of either gender aged 40-75 years old inclusively with verified atherosclerotic cerebrovascular lesions (ICD-10 code - "Cerebral atherosclerosis" \\[I67.2\\]), with cognitive disorders (МоСА\\<26), without relevant incapacity (mRs≤1).\n\nAt screening visit (Visit 1, from day - 5 to day 0), after signing patient information sheet (informed consent form) for participation in the clinical study the patient\'s complaints and medical history will be collected and objective examination will be carried out. The investigator will assess intensity of cognitive disorders using MoCA, extent of functional capacity using mRs .\n\nIf the patient meets inclusion criteria and has no exclusion criteria at Visit 2 (Day 0) he/she will be randomized to one of two groups: group 1 will receive Divaza at 2 tablets 3 times a day; group 2 - placebo using study drug scheme.\n\nLaboratory examination will be performed.\n\n1. oxidant and antioxidant systems (Fe2+-induced chemoluminescence method, ELISA) defining: 1.1. level of preformed LP products, predominantly lipid hydroperoxides; 1.2. low and very low density lipoprotein resistance to LP; 1.3. lipoprotein potential for oxidation; 1.4. serum NO product concentration (Griess reaction).\n2. compensatory potential of endothelium and its ability for adequate regulation of vascular tone with : 2.1. determination of platelet aggregation with bandage sign; 2.2. MAH duplex scanning. Procedures of Visit 2 may be performed on day of Visit 1 if general rules for blood collection are met, at that previously performed procedures will not be repeated.\n\nThe first administration of Divaza or Placebo will be performed at Visit 2 at medical site in the investigator\'s presence. The patient monitoring and therapy will last for 12 weeks during which 3 additional visits will be made.\n\nAt Visit 3 (Week 4±5 days) the investigator will collect the complaints, perform objective examination, evaluate intensity of cognitive disorders (MoCA). The investigator will monitor the prescribed, basic and concomitant therapy, evaluate therapeutic safety.\n\nAt Visit 4 (Week 8±5 days) the investigator will make a phone call to the patient to evaluate safety of the treatment.\n\nAt the final Visit 5 (Weeks 12±5 days) the investigator will evaluate intensity of cognitive disorders (MoCA). Laboratory examination of oxidant and antioxidant systems, compensatory potential of endothelium and its potential for adequate vascular tone regulation. The investigator will monitor the prescribe, basic and concomitant therapy, evaluate therapeutic safety and treatment compliance.\n\nDuring the study basic, concomitant therapy will be allowed except for the products indicated in the section "Prohibited concomitant therapy".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both genders aged 40-75 years old inclusive.\n2. Diagnosis of cerebral atherosclerosis verified by all three signs:\n\n * underlying vascular disease (atherosclerosis and/or hypertension) and focal neurological symptoms combined with cerebral symptoms (headache, dizziness, tinnitus, impaired memory, working capacity);\n * ultrasound signs of atherosclerotic cerebrovascular lesions (according to MAH duplex scanning within 6 months preceding the patient enrollment into the study);\n * signs of morphological changes in the brain based on neuroimaging (CT/MRI 1.0-1.5 T) (subcortical and periventricular leukoaraiosis and/or focal changes in grey matter and white matter in the form of postischemic cysts and/or lacunar strokes and/or diffuse atrophic changes in the form of dilated cardiovascular system or subarachnoidal spaces).\n3. Cognitive disorders (MoCa \\<26).\n4. Patients with unchanged dose and combination of basic therapy of cerebral atherosclerosis and hypertension during the previous month.\n5. Patients who gave their consent to use reliable contraception during the study.\n6. Availability of signed patient information sheet and informed consent form for participation in the clinical trial.\n\nExclusion Criteria:\n\n1. History of subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral tumour or another disease resulting in neurological disorders.\n2. Ischemic-type stroke or any other acute cerebrovascular accident less than 6 months prior to the study with Modified Rankin Scale (mRs) \\> 1 .\n3. Cardiac sources of high risk or medium risk embolism (TOAST criteria).\n4. Signs of acute or exacerbated chronic infectious diseases at or less than 2 weeks prior to screening.\n5. History of CNS diseases including:\n\n * Inflammatory CNS diseases (G00-G09)\n * Systemic Atrophies Primarily Affecting the CNS (G10-G13)\n * Other degenerative diseases of the nervous system (G30-G32)\n * Demyelinating diseases of the CNS (G35-G37).\n6. Dementia (F00-F03).\n7. Previously diagnosed cardiovascular diseases with functional class III or IV (according to New York Heart Association, 1964).\n8. Hypothyroidism, diabetes mellitus and other somatic diseases at decompensation stage.\n9. Uncontrollable hypertension: SBP \\> 180 mm Hg and/or DBP \\> 110 mm Hg.\n10. Diseases of lower limb veins (lower limb varicose veins, deep venous thrombosis, etc.) at decompensation stage.\n11. Any other severe concomitant pathology which, according to the investigator, may interfere with the patient\'s participation in the study.\n12. History/suspicion of oncology of any location (except for benign neoplasms).\n13. Allergy/intolerance of any component of the drug products used in the therapy.\n14. Hereditary lactose intolerance.\n15. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.\n16. Pregnancy, breast-feeding.\n17. History of treatment non-compliance, psychiatric disorders, alcoholism or drug abuse which, according to the investigator, may interfere with the study procedures.\n18. Use of any medicine indicated in the section "Prohibited concomitant treatment" within 1 month prior to enrollment.\n19. Participation in other clinical trials in the previous 3 months.\n20. Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the study investigator, or has another conflict of interests. \'Immediate relative\' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).\n21. Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company\'s employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).'}, 'identificationModule': {'nctId': 'NCT03485495', 'briefTitle': 'Clinical Trial of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients With Cerebral Atherosclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Materia Medica Holding'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MMH-DV-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Divaza', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.', 'interventionNames': ['Drug: Divaza']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Divaza', 'type': 'DRUG', 'description': 'Oral administration.', 'armGroupLabels': ['Divaza']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141060', 'city': 'Korolyov', 'country': 'Russia', 'facility': 'Limited Liability Company "Family policlinic no. 4"', 'geoPoint': {'lat': 55.91417, 'lon': 37.82556}}, {'zip': '115516', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow City Clinical Hospital after V.M. Buyanov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119049', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital No. 1 named after. N.I. Pirogov Moscow Department of Health', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution Federal Research and Clinical Center of Physical-Chemical Medicine Federal Medical Biological Agency', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119992', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '1253678', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budget Scientific Institution "Scientific Center of Neurology"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '150000', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150030', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'State budgetary institution of health care of the Yaroslavl region "Regional Clinical Hospital"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materia Medica Holding', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}