Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-01 @ 1:37 PM
Study NCT ID:
NCT05359068
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-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': 'C000709209', 'term': 'SPH3127'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 957}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12', 'timeFrame': 'Measure at week 12 of treatment.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10', 'timeFrame': 'Measured at week 2, 4, 6, 8 and 10 of treatment.'}, {'measure': 'Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.', 'timeFrame': 'Measured at week 2, 4, 6, 8, 10, and 12 of treatment.'}, {'measure': 'Total effective rate at week 2, 4, 6, 8, 10 and 12', 'timeFrame': 'Measured at week 2, 4, 6, 8, 10, and 12 of treatment.'}, {'measure': 'Rate of reaching target blood pressure at week 2, 4, 6, 8, 10 and 12', 'timeFrame': 'Measured at week 2, 4, 6, 8, 10, and 12 of treatment.'}, {'measure': 'Number of subjects with adverse event.', 'timeFrame': '12 weeks.'}, {'measure': 'Plasma concentration of SPH3127.', 'timeFrame': '12 weeks.'}, {'measure': 'Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events', 'timeFrame': '12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female of age ≥18 years;\n2. Diagnosed with mild-moderate essential hypertension;\n3. Participant has understood the study-required procedures, voluntarily signed informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;\n2. Suffered by severe heart disease within 6 months;\n3. Suffered by severe cerebrovascular disease within 6 months;\n4. Suffered by severe or malignant retinopathy;\n5. Out of controlled diabetes;\n6. History of malignant tumor;\n7. History of mental disorder;\n8. Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;\n9. Alcohol or drug abuse;\n10. Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;\n11. Assessed by the investigators as unsuitable for participating in the study.'}, 'identificationModule': {'nctId': 'NCT05359068', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Pharmaceuticals Holding Co., Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Double-Dummy, Positive Parallel Controlled Study to Evaluate the Efficacy and Safety in Treatment of Mild-moderate Essential Hypertension', 'orgStudyIdInfo': {'id': 'SPH3127-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1 Arm A', 'description': '1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.', 'interventionNames': ['Drug: SPH3127 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 Arm B', 'description': '2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.', 'interventionNames': ['Drug: SPH3127 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 Arm C', 'description': '4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.', 'interventionNames': ['Drug: SPH3127 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 Arm D', 'description': '4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.', 'interventionNames': ['Drug: Valsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 Arm A', 'description': '2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.', 'interventionNames': ['Drug: SPH3127 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 Arm B', 'description': '2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.', 'interventionNames': ['Drug: Valsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 3', 'description': '2 SPH3127 tablets, once daily for 40 weeks.', 'interventionNames': ['Drug: SPH3127 tablet']}], 'interventions': [{'name': 'SPH3127 tablet', 'type': 'DRUG', 'description': '1 tablet', 'armGroupLabels': ['Stage 1 Arm A']}, {'name': 'SPH3127 tablet', 'type': 'DRUG', 'description': '2 tablets', 'armGroupLabels': ['Stage 1 Arm B']}, {'name': 'SPH3127 tablet', 'type': 'DRUG', 'description': '4 tablets', 'armGroupLabels': ['Stage 1 Arm C']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': '1 valsartan capsule', 'armGroupLabels': ['Stage 1 Arm D']}, {'name': 'SPH3127 tablet', 'type': 'DRUG', 'description': '2 tablets', 'armGroupLabels': ['Stage 2 Arm A', 'Stage 3']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': '1 valsartan capsule', 'armGroupLabels': ['Stage 2 Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101299', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Pinggu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '404037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Affiliated Hospital of Chongqing Three Gorges Medical College', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '730030', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Lanzhou University Second Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '510310', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Second Provincial General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '519041', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '545026', 'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': "Liuzhou people's Hospital", 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'zip': '571199', 'city': 'Sanya', 'state': 'Hainan', 'country': 'China', 'facility': "Hainan Third People's Hospital", 'geoPoint': {'lat': 18.25435, 'lon': 109.50947}}, {'zip': '061011', 'city': 'Cangzhou', 'state': 'Hebei', 'country': 'China', 'facility': 'Cangzhou Central Hospital', 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'zip': '050030', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Third Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 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'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'XiangYa Hospital CentralSouth University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410012', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '750306', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '024099', 'city': 'Chifeng', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Chifeng Municipal Hospital', 'geoPoint': {'lat': 42.26833, 'lon': 118.96361}}, {'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'The Affiliated Hospital of Inner Mongolia Medical University', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'zip': '210003', 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'facility': 'Affiliated Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}, {'zip': '110022', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110067', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "The People's Hospital of Liaoning Province", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '750003', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '750003', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': "The First People's Hospital of Yinchuan", 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiaotong 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