Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT06671392
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2024-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase III Study to Efficacy and Safety of DWC202405/DWC202313 and DWC202314 in Patients with 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Randomized, Double-blind, Parallel design, Phase III study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Average systolic blood pressure (MSSBP) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP \\< 180 mmHg and MSDBP \\< 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP \\< 180 mmHg and MSDBP \\< 110 mmHg are applied to patients with the following diseases.\n\nExclusion Criteria:\n\n* If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg\n* Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg'}, 'identificationModule': {'nctId': 'NCT06671392', 'briefTitle': 'A Phase III Study to Efficacy and Safety of DWC202405/DWC202313 and DWC202314 in Patients with Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel Design, Phase III Study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405', 'orgStudyIdInfo': {'id': 'DW_DWJ1622301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWC202405', 'interventionNames': ['Drug: DWC202405']}, {'type': 'EXPERIMENTAL', 'label': 'DWC202405, DWC202314 / DWC202313, DWC202314', 'interventionNames': ['Drug: DWC202405, DWC202314', 'Drug: DWC202313, DWC202314']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DWC202405, DWC202314P / DWC202313, DWC202314P', 'interventionNames': ['Drug: DWC202405, DWC202314P', 'Drug: DWC202313, DWC202314P']}], 'interventions': [{'name': 'DWC202405', 'type': 'DRUG', 'description': '5/20mg, 1 tablet, Oral, Once a day', 'armGroupLabels': ['DWC202405']}, {'name': 'DWC202405, DWC202314', 'type': 'DRUG', 'description': '5/20mg + 1.5mg, 1 tablet, Oral, Once a day', 'armGroupLabels': ['DWC202405, DWC202314 / DWC202313, DWC202314']}, {'name': 'DWC202405, DWC202314P', 'type': 'DRUG', 'description': '5/20mg + 1.5mg, 1 tablet, Oral, Once a day', 'armGroupLabels': ['DWC202405, DWC202314P / DWC202313, DWC202314P']}, {'name': 'DWC202313, DWC202314', 'type': 'DRUG', 'description': '10/40mg + 1.5mg, 1 tablet, Oral, Once a day', 'armGroupLabels': ['DWC202405, DWC202314 / DWC202313, DWC202314']}, {'name': 'DWC202313, DWC202314P', 'type': 'DRUG', 'description': '10/40mg + 1.5mg, 1 tablet, Oral, Once a day', 'armGroupLabels': ['DWC202405, DWC202314P / DWC202313, DWC202314P']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Korea University ANAM Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jeon', 'role': 'CONTACT', 'email': 'sgcho@daewoong.co.kr', 'phone': '82-02-2228-8523'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}