Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-02-22 @ 4:11 PM
Study NCT ID:
NCT02513927
Status:
UNKNOWN
Last Update Posted:
2015-09-30
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D008790', 'term': 'Metoprolol'}, {'id': 'D009543', 'term': 'Nifedipine'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour Ambulatory Blood Pressure Monitoring', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'plasma uric acid level', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood pressure variability', 'CCB', 'beta-receptor blockers', 'heart rate'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP.\n\nAt present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.', 'detailedDescription': 'Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP.\n\nThe hypertension prevalences in the high latitude and cold regions are much higher than those in the low latitude and warm regions. In China, the prevalences of hypertension are gradually increased from the South to the North. Heilongjiang province is the "high-risk" region for hypertension, with a prevalence of 30.48%. This may be due to the combined effects of lower average temperature and higher intake of salt and saturated fatty acid, which Increased sympathetic nerve excitability, and eventually lead to elevation of blood pressure. Therefore, it is essential to formulate the best treatment of hypertension according with the physical characteristics of northern Chinese.\n\nAt present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged between 18 and 75 included years old\n* Postmenopausal women who are no more than 75 years older.\n* Patients with essential mild to moderate uncomplicated hypertension (DBP\\<110mmHg and SBP\\<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,\n* Without antihypertensive treatment in 2 weeks.\n\nExclusion Criteria:\n\n* History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.\n* History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.\n* History of renal impairment.\n* History of Type I diabetes mellitus or Type II diabetes uncontrolled.\n* History of liver impairment.\n* History of alcoholism or drug abuse.\n* Known symptomatic orthostatic hypotension.\n* Contra-indications to treatment with investigate products.'}, 'identificationModule': {'nctId': 'NCT02513927', 'briefTitle': 'The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study', 'orgStudyIdInfo': {'id': 'HT-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'To observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.Then to observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment.', 'interventionNames': ['Drug: metoprolol', 'Drug: Nifedipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'To observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Then to observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.', 'interventionNames': ['Drug: metoprolol', 'Drug: Nifedipine']}], 'interventions': [{'name': 'metoprolol', 'type': 'DRUG', 'description': 'Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.', 'armGroupLabels': ['A', 'B']}, {'name': 'Nifedipine', 'type': 'DRUG', 'description': 'Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'state': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Jingyan Piao, MM', 'role': 'CONTACT', 'email': '411483521@qq.com', 'phone': '86-451-85555333'}, {'name': 'Yujiao Pan, MM', 'role': 'CONTACT', 'email': 'panyujiao@163.com', 'phone': '86-451-85555671'}], 'facility': 'Twenty-four-hour ambulatory BP monitoring', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Yue Li, PHD', 'role': 'CONTACT', 'email': 'ly99ly@vip.163.com', 'phone': '86-451-85555673'}, {'name': 'Jing Shi, MM', 'role': 'CONTACT', 'email': 'yidashijing@163.com', 'phone': '86-451-85555672'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}