Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-02 @ 11:54 AM
Study NCT ID:
NCT02248961
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}, {'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'berezhanskiy@rpharm.ru', 'phone': '0074959567937', 'title': 'Boris Berezhanskiy, Medical Advisor', 'phoneExt': '2468', 'organization': 'R-Pharm'}, 'certainAgreement': {'otherDetails': 'Any study related information could be made public availiable only after Sponsors written permission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '18 weeks', 'description': 'The number and percent of subjects and number and group of AEs will be performed within every organ/system group', 'eventGroups': [{'id': 'EG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 20, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 15, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'title': 'SBP at Baseline', 'categories': [{'measurements': [{'value': '152.9', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '151.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-25.2', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-24.3', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciUpperLimit': '1.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.00', 'groupDescription': 'The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).\n\nTest of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12 of treatment', 'description': 'The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'title': 'DBP at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4 of treatment', 'description': 'The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4.'}, {'type': 'SECONDARY', 'title': 'Change in DBP After 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'title': 'DBP at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.579', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8 of treatment', 'description': 'The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of DBP at week 8 minus Value of SBP at baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8.'}, {'type': 'SECONDARY', 'title': 'Change in DBP After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'title': 'DBP at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.466', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12 of treatment', 'description': 'The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of DBP at week 12 minus Value of SBP at baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 12'}, {'type': 'SECONDARY', 'title': 'Change in SBP After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'title': 'SBP at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152.9', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '151.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.7', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-17.6', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.118', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4 of treatment', 'description': 'The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of SBP at week 4 minus Value of SBP at baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4'}, {'type': 'SECONDARY', 'title': 'Change in SBP After 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'title': 'SBP at Baseline', 'categories': [{'measurements': [{'value': '152.9', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '151.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '-23.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-23.9', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.662', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8 of treatment', 'description': 'The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Responded on Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'OG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.143', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12 of treatment', 'description': 'The subject will be considered a responder if SBP (when seated) \\<140 mmHg or SBP decrease is \\>10% from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'FG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unmet inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants recruitment was conducted in 13 clinical sites of Moscow and Saint-Petersburg between May and October of 2014', 'preAssignmentDetails': 'Duration of screening period was up to 14 days depended on prior antihypertensive treatment. 184 patients were screened, 179 randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Kanarb (Fimasartan)', 'description': '60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period'}, {'id': 'BG001', 'title': 'Cozaar® (Losartan)', 'description': '50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'BG000', 'lowerLimit': '25.6', 'upperLimit': '75.9'}, {'value': '53.8', 'groupId': 'BG001', 'lowerLimit': '21.9', 'upperLimit': '73.2'}, {'value': '53.6', 'groupId': 'BG002', 'lowerLimit': '21.9', 'upperLimit': '75.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'European', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'BG000', 'lowerLimit': '20.3', 'upperLimit': '50.5'}, {'value': '28.9', 'groupId': 'BG001', 'lowerLimit': '20.7', 'upperLimit': '41.7'}, {'value': '29.1', 'groupId': 'BG002', 'lowerLimit': '20.3', 'upperLimit': '50.5'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index calculated as weight(kg)/height(m\\^2)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Arterial hypertension (AH) duration', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '19.2'}, {'value': '6.2', 'groupId': 'BG001', 'lowerLimit': '0.3', 'upperLimit': '33.1'}, {'value': '6.0', 'groupId': 'BG002', 'lowerLimit': '0.3', 'upperLimit': '33.1'}]}]}], 'paramType': 'MEAN', 'description': 'The duration of AH in patients at study inclusion in population of all randomized patients', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hypertension grade', 'classes': [{'title': 'Grade I', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Grade II', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The grade of blood pressure increase was determined in accordance with Russian guidelines (fourth revision) "Diagnosis and treatment of arterial hypertension".\n\nGrade I AH: sistolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg\n\nGrade II AH: sistolic blood pressure (SBP) 160-179 mmHg and/or diastolic blood pressure (DBP) 100-109 mmHg', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic heart failure (CHF) NYHA Class I', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients with no limitation of physical activity (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea - shortness of breath) but having symptoms of chronic heart failure could be defined as NYHA (New-York Heart Association) Class I of chronic heart failure', 'unitOfMeasure': 'Participants'}, {'title': 'Prior therapy for arterial hypertension', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'categories': [{'title': 'Smoker', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Has never smoked', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Smoker-in-the-past', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol history', 'classes': [{'categories': [{'title': 'Drinking', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Never-drinking', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Drinking-in-the-past', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2014-09-22', 'resultsFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-05', 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment', 'timeFrame': 'Baseline and week 12 of treatment', 'description': 'The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).'}], 'secondaryOutcomes': [{'measure': 'Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment', 'timeFrame': 'Baseline and week 4 of treatment', 'description': 'The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).'}, {'measure': 'Change in DBP After 8 Weeks of Treatment', 'timeFrame': 'Baseline and week 8 of treatment', 'description': 'The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of DBP at week 8 minus Value of SBP at baseline).'}, {'measure': 'Change in DBP After 12 Weeks of Treatment', 'timeFrame': 'Baseline and week 12 of treatment', 'description': 'The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of DBP at week 12 minus Value of SBP at baseline).'}, {'measure': 'Change in SBP After 4 Weeks of Treatment', 'timeFrame': 'Baseline and week 4 of treatment', 'description': 'The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of SBP at week 4 minus Value of SBP at baseline).'}, {'measure': 'Change in SBP After 8 Weeks of Treatment', 'timeFrame': 'Baseline and week 8 of treatment', 'description': 'The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.\n\n"Change" was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).'}, {'measure': 'Number of Subjects Who Responded on Therapy', 'timeFrame': 'Week 12 of treatment', 'description': 'The subject will be considered a responder if SBP (when seated) \\<140 mmHg or SBP decrease is \\>10% from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \\& DOHME B.V., Netherlands, tablet 50/100 mg in adult patients with Grade I-II arterial hypertension in 12 weeks of therapy', 'detailedDescription': '1. To evaluate efficacy of 12-week Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \\& DOHME B.V., Netherlands, tablet 50/100 mg in adult patients with Grade I-II arterial hypertension.\n2. To evaluate safety of 12-week Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \\& DOHME B.V., Netherlands, tablet 50/100 mg in adult patients with Grade I-II arterial hypertension.\n3. Assess the pharmacokinetics parameters of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea in adult patients with arterial hypertension I-II stage after a single dose.\n\nStarting dose of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea is 60 mg, orally, once a day in the morning.\n\nThe planned study duration for each subject is 18 weeks maximum:\n\nThe screening period could takes up to 2 weeks (including the 1-week "wash-out" period ) - the screening period duration depends on the prior anti-hypertensive therapy:\n\n* "naive" subjects who never received therapy (which must be reflected in the source documents), may be randomized after completion of all screening procedures;\n* Subjects receiving anti-hypertensive therapy which may be discontinued without prior dose reduction must undergo a 7 days "wash-out" period, so the screening period will take at least 7 days;\n* Subjects, receiving anti-hypertensive therapy which requires dose reduction before discontinuation must undergo the 7 days "wash-out" period after the last dose administration, so the screening period will consist of dose reduction period and a "wash-out" period.\n\nTreatment period - 12 weeks. Follow-up period - 4 weeks. The subjects will visit the clinical site every 4 weeks to measure ABP. The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).\n\nIf necessary, the dose of the study drug may be increased based on the assessment of patient\'s condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator\'s judgment, indicated in source documents).\n\nWhen possibilities are, the patient should be administrated by the study medication at the same time in the morning. Governing conditions for defining the time of the drug administration is the subject comfort and the time of its visits the research center.\n\nIf laboratory tests are scheduled, a patient should come to the research center fasting (food is prohibited for 8 hours before the visit).\n\nAll of the clinical evaluations are conducted on the next morning after taking the medication. On the visit day a patient comes to the research center not taking the drug, and after all the planned procedures are conducted the patient is administrated by the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of both sex aged 18-75 inclusively.\n2. Subjects who signed their written Informed Consent for participation in the study and willing to adhere to all Protocol procedures.\n3. Subjects with documented diagnosis of grade I-II primary arterial hypertension within at least 3 months before screening.\n4. Systolic blood pressure (SBP) (when seated) at Screening (Day -14)\n\n * For subjects administered with anti-hypertensive therapy: SBP ≤ 179 Hg\n * For subjects receiving no anti-hypertensive therapy (so called \'naïve\' patients): 140≥SBP ≤179.\n5. As per investigator\'s judgment, subjects with controlled arterial hypertension must benefit from the therapy switch to Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \\& DOHME B.V., Netherlands, .\n6. For subjects administered with anti-hypertensive drugs: the anti-hypertensive drug may be safely cancelled during the "wash-out" period according to the investigator\'s judgment.\n7. For women of child-bearing potential: negative urine pregnancy test at screening (Day -14). 8. Systolic blood pressure (SBP) (when seated) at Randomization (Day 0) ≥140 mmHg and ≤179 mmHg.\n\n9\\. For women of child-bearing potential: negative urine pregnancy test at Randomization (Day 0)\n\nExclusion Criteria:\n\n1. Grade III Arterial Hypertension.\n2. Arterial hypotension (SPB ≤100 mm Hg) at Screening (Day -14) and/or Randomization (Day 0).\n3. Subjects needing treatment with more than one anti-hypertensive drug (more than one active substance, including complex drugs).\n4. Secondary (symptomatic) arterial hypertension.\n5. Known bilateral renal arterial stenosis or unilateral renal arterial stenosis.\n6. Hyperpotassemia \\>5,0 mmol/l (as per blood biochemistry results at Screening).\n7. Primary hyperaldosteronism.\n8. Known hypersensitivity to angiotensin-II receptors antagonists or any other study drug or comparator component.\n9. Contraindications for use of angiotensin-II receptors antagonists.\n10. Myocardial infarction and or unstable angina, and/or acute cerebrovascular accident/transient ischemic attack, and/or percutaneous coronary intervention, and/or coronary arterial bypass graft, acute coronary arteries involvement, and/or obliterative vascular atherosclerosis of low extremities, and/or grade III and IV retinopathy in anamnesis.\n11. Clinically significant cardiac valves damage.\n12. Cardiomyopathies\n13. Chronic Heart failure (CHF) (except for CHF FC I NYHA).\n14. Creatinine clearance less than 60 ml/min/1.73m2 calculated by Cockroft-Gault formula.\n15. Known moderate to severe hepatic insufficiency and/or transaminase increase: AST and/or ALT ≥2\\*ULN.\n16. History of infections (HIV, hepatitis B or C, syphilis).\n17. Uncontrolled Diabetes mellitus, Glycosylated hemoglobin level (HbA1c) \\>7%.\n18. Severe systemic diseases, such as gastro-intestinal tract diseases, autoimmune disorders, blood disorders and other conditions which may affect on the study drugs\' absorption, distribution and and excretion.\n19. Clinically significant abnormalities of laboratory parameters.\n20. Drug or alcohol addiction, psychiatric disorders.\n21. Medical history of oncological disease within 5 years before screening.\n22. Subjects with biliary tracts obstruction.\n23. Subjects with genetic disorders, such as galactose intolerance, congenital lactase insufficiency and glucose-galaclose malabsorption syndrome.\n24. Any other acute disease or progression and/or decompensation at the moment of enrollment\n25. Necessity to administer or administration of prohibited concomitant drugs from the "List of Prohibited Drugs" within 14 days before enrollment\n26. Pregnancy or breast-feeding period; fertile women not using adequate contraception methods\n27. Participation in another clinical trial within 3 months before Screening.\n28. Other medical or psychiatric conditions or lab abnormalities that may increase potential risk associated with study participation and IP administration, or that may affect study results interpretation and as per investigator\'s judgment, make the subject ineligible.\n29. Study site personnel or Sponsor\'s representatives immediately involved in the study.\n30. Subjects, excluded from the study may not be included in it again.'}, 'identificationModule': {'nctId': 'NCT02248961', 'briefTitle': 'Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'Open-label, Randomized, Multicenter, Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan), Manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, Tablets 60/120 mg and Cozaar® (Losartan), Manufactured by MERCK SHARP & DOHME B.V., Netherlands, Tablet 50/100 mg in Adult Patients With Grade I-II Arterial Hypertension', 'orgStudyIdInfo': {'id': 'CC09042014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kanarb (Fimasartan)', 'description': '88 subjects will receive Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg for 12 weeks', 'interventionNames': ['Drug: Fimasartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cozaar® (Losartan)', 'description': '88 subjects will receive Cozaar® (Losartan), manufactured by MERCK SHARP \\& DOHME B.V., Netherlands, tablets 50/100 mg for 12 weeks', 'interventionNames': ['Drug: Losartan']}], 'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'otherNames': ['Kanarb'], 'description': "Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).\n\nIf necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents).\n\nWhen possibilities are, the patient should be administrated by the study medication at the same time in the morning.", 'armGroupLabels': ['Kanarb (Fimasartan)']}, {'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['Cozaar®'], 'description': 'Cozaar® (Losartan), manufactured by MERCK SHARP \\& DOHME B.V., Netherlands, tablets 50/100 mg', 'armGroupLabels': ['Cozaar® (Losartan)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Institution "Russian Cardiology Research and Production Complex" of the Ministry of Health and Social Development of the Russian Federation (FSI "Cardiology" Russian Healthcare Ministry)', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Health Department "City Clinical Hospital № 81"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'State Research Center for Preventive Medicine of Ministry of Health of the Russian gederation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Pushkin', 'country': 'Russia', 'facility': 'St. Petersburg State health agency "City Hospital number 38 it. NA Semashko "', 'geoPoint': {'lat': 59.71417, 'lon': 30.39642}}, {'zip': '190000', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State healthcare Institution "City Hospital number 28" "Maximilianovskaya"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Clinical Hospital n. a. 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