Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05899920
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010599', 'term': 'Pharmacokinetics'}, {'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D002620', 'term': 'Pharmacological and Toxicological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol', 'timeFrame': 'day 1', 'description': 'Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antihypertensive drugs', 'concentration', 'HPLC MS/MS'], 'conditions': ['Resistant Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form;\n* An established diagnosis of AH based on the Clinical Guidelines "Arterial hyperten-sion in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;\n* Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines "Arterial hypertension in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .\n* Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;\n* Fertile female patients must use proper methods of contraception throughout the study period.\n\nExclusion Criteria:\n\n* Patient\'s connection with the organization or conducting of the study;\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05899920', 'acronym': 'SAGA', 'briefTitle': 'Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ryazan State Medical University'}, 'officialTitle': 'Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy', 'orgStudyIdInfo': {'id': 'SAGA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Controlled arterial hypertension', 'description': 'Controlled arterial hypertension according the results of 24-hour blood pressure monitoring.\n\nBlood samples will be taken for pharmacokinetics and pharmacogenetics', 'interventionNames': ['Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogenetics']}, {'type': 'EXPERIMENTAL', 'label': 'Uncontrolled arterial hypertension', 'description': 'Uncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring.\n\nBlood samples will be taken for pharmacokinetics and pharmacogenetics', 'interventionNames': ['Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogenetics']}], 'interventions': [{'name': 'Blood samples will be taken for pharmacokinetics and pharmacogenetics', 'type': 'DIAGNOSTIC_TEST', 'description': 'To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide', 'armGroupLabels': ['Controlled arterial hypertension', 'Uncontrolled arterial hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '390026', 'city': 'Ryazan', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey V Seleznev, MD, PhD', 'role': 'CONTACT', 'email': 'sv.seleznev@gmail.com', 'phone': '+79105749526'}, {'name': 'Alexey V Shchulkin, MD, PhD', 'role': 'CONTACT', 'email': 'alekseyshulkin@rambler.ru', 'phone': '+79209520024'}, {'name': 'Sergey S Yakushin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pavel Yu Mylnikov, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elena N Yakusheva, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalia N Nikulina, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ryzan State Medical University', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}], 'centralContacts': [{'name': 'Sergey V Seleznev, MD, PhD', 'role': 'CONTACT', 'email': 'sv.seleznev@gmail.com', 'phone': '+79105749526'}, {'name': 'Alexey V Shchulkin, MD, PhD', 'role': 'CONTACT', 'email': 'alekseyshulkin@rambler.ru', 'phone': '+79209520024'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ryazan State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}