Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01970059
Status:
UNKNOWN
Last Update Posted:
2013-10-25
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 302}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-22', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8', 'timeFrame': 'Baseline and Week 8'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or Females\n* Aged from 18 to 70 years\n* Had a history of essential hypertension\n* Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg\n\nExclusion Criteria:\n\n* Malignant hypertension\n* Average sitting systolic blood pressure≧180mmHg\n* Type 2 diabetes with hemoglobin A1c≥9%\n* Type 1 diabetes\n* New York Heart Association class Ⅱ-Ⅳ congestive heart-failure\n* Unstable angina\n* Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place\n* Atrial fibrillation\n* Bradycardia (\\<60 bpm, seated)\n* Asthma or other obstructive pulmonary disease\n* History of myocardial infarction\n* Stroke in the 6 months before screening\n* Known contraindications to β-adrenergic blocker therapy\n* Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase\\>3 times upper limit of normal\n* Crea\\>2 times upper limit of normal\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01970059', 'briefTitle': 'A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension', 'orgStudyIdInfo': {'id': 'KWDLEH2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended-Release Carvedilol Sulfate', 'description': '18-72mg/d,po', 'interventionNames': ['Drug: Extended-Release Carvedilol Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sustained-release Metoprolol Succinate', 'description': '47.5-190mg/d,po', 'interventionNames': ['Drug: Sustained-release Metoprolol Succinate']}], 'interventions': [{'name': 'Extended-Release Carvedilol Sulfate', 'type': 'DRUG', 'armGroupLabels': ['Extended-Release Carvedilol Sulfate']}, {'name': 'Sustained-release Metoprolol Succinate', 'type': 'DRUG', 'armGroupLabels': ['Sustained-release Metoprolol Succinate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Gansu Provincial Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Zhang, Professor', 'role': 'CONTACT', 'email': 'yun-zhang@163.com', 'phone': '86 135731022060'}, {'name': 'Yun Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Taizhou Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'zip': '100053', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Xuan Wu hospital affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '11691777', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Tongren hospital affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Longhua Hospital Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yun Zhang, Professor', 'role': 'CONTACT', 'email': 'yun-zhang@163.com', 'phone': '86 135731022060'}], 'overallOfficials': [{'name': 'Yun Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}