Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT02031861
Status:
COMPLETED
Last Update Posted:
2015-02-05
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009543', 'term': 'Nifedipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'clinical laboratory test and adverse event', 'timeFrame': '12 weeks'}], 'primaryOutcomes': [{'measure': 'change in morning blood pressure surge from baseline', 'timeFrame': '12 weeks'}, {'measure': 'change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'change in morning blood pressure from baseline', 'timeFrame': '12 weeks'}, {'measure': 'T/P ratio', 'timeFrame': '12 weeks'}, {'measure': 'average reduction in systolic blood pressure from 18 to 24 hours after administration', 'timeFrame': '12 weeks'}, {'measure': 'average reduction in diastolic blood pressure from 18 to 24 hours after administration', 'timeFrame': '12 weeks'}, {'measure': 'smoothness index', 'timeFrame': '12 weeks'}, {'measure': 'change in morning blood pressure surge from baseline', 'timeFrame': '8 weeks'}, {'measure': 'change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline', 'timeFrame': '8 weeks'}, {'measure': 'change in morning blood pressure from baseline', 'timeFrame': '8 weeks'}, {'measure': 'T/P ratio', 'timeFrame': '8 weeks'}, {'measure': 'average reduction in systolic blood pressure from 18 to 24 hours after administration', 'timeFrame': '8 weeks'}, {'measure': 'average reduction in diastolic blood pressure from 18 to 24 hours after administration', 'timeFrame': '8 weeks'}, {'measure': 'smoothness index', 'timeFrame': '8 weeks'}, {'measure': 'change in systolic blood pressure (SBP) from baseline', 'timeFrame': '12 weeks'}, {'measure': 'change in diastolic blood pressure (DBP) from baseline', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily participate and must sign informed consent form\n* Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)\n* Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg\n\nExclusion Criteria:\n\n* Secondary hypertension and malignant hypertension\n* Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures\n* Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications\n* Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia\n* Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)\n* Kock pouch\n* Sever gastrointestinal stenosis\n* Abnormal laboratory values with clinical significance, including serum potassium \\<3.5 or \\>5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) \\>2-fold upper limit of normal (ULN), Cr \\>ULN\n* Uric acid \\>ULN with the diagnosis of gout\n* Gastrointestinal abnormalities or surgery that may interfere with drug absorption\n* Hyperthyroidism or hypothyroidism\n* Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure\n* Heavy smokers (\\>25 cigarettes every day), alcoholics (\\>250 ml liquor every day), drug addicts\n* Psychological diseases, acrasia, cannot express explicitly\n* Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure\n* Anxiety disorders, depression or cannot follow study protocol\n* BMI \\>30\n* Night shift, irregular sleep patterns or insomnia\n* participate in other clinical trials within 3 months\n* other conditions that investigators consider unsuitable for participation'}, 'identificationModule': {'nctId': 'NCT02031861', 'briefTitle': 'Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Shyndec Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Random, Open Label, Active Comparator-controlled Parallel Study to Evaluate the Efficacy of Nifedipine Controlled-released Tablets (Xin Ran) in Patients With Mild to Moderate Essential Hypertension', 'orgStudyIdInfo': {'id': 'CH-004PIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nifedipine CR tablets (Xin Ran)', 'description': 'Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.', 'interventionNames': ['Drug: nifedipine CR tablets (Xin Ran)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nifedipine CR tablets (Adalat)', 'description': 'Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.', 'interventionNames': ['Drug: nifedipine CR tablets (Adalat)']}], 'interventions': [{'name': 'nifedipine CR tablets (Xin Ran)', 'type': 'DRUG', 'armGroupLabels': ['nifedipine CR tablets (Xin Ran)']}, {'name': 'nifedipine CR tablets (Adalat)', 'type': 'DRUG', 'armGroupLabels': ['nifedipine CR tablets (Adalat)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Pingjin Gao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Shyndec Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}