Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT05878561
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2023-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy
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': 'C558933', 'term': 'fimasartan'}, {'id': 'D007190', 'term': 'Indapamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sitting systolic blood pressure', 'timeFrame': '8weeks from Baseline Visit', 'description': 'The change of sitting systolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Sitting systolic blood pressure', 'timeFrame': '4weeks from Baseline Visit', 'description': 'The change of sitting systolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Inclusion Criteria:\n\n * Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:\n\n * Naïve : 140 mmHg ≤ SiSBP \\< 180 mmHg\n * Use antihypertensive drugs : 130 mmHg ≤ SiSBP \\< 180 mmHg\n * Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:\n\n * Selected reference arm : 140 mmHg ≤ SiSBP \\< 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP \\< 180 mmHg)\n * Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2)\n * Voluntarily provided a written consent to participate in this clinical study\n * Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion\n* Exclusion Criteria:\n\n * Patients taking three or more antihypertensive drugs of different families\n * Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2)\n * Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)\n * Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)\n * Patients with orthostatic hypotension accompanied by symptoms\n * Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials"}, 'identificationModule': {'nctId': 'NCT05878561', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg', 'orgStudyIdInfo': {'id': 'BR-FIC-CT-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fimasartan + Indapamide', 'description': 'Treatment Period I, II', 'interventionNames': ['Drug: Fimasartan + Indapamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fimasartan + Indapamide placebo', 'description': 'Treatment Period I, II', 'interventionNames': ['Drug: Fimasartan + Indapamide placebo']}], 'interventions': [{'name': 'Fimasartan + Indapamide', 'type': 'DRUG', 'otherNames': ['I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2'], 'description': 'a fixed dose combination', 'armGroupLabels': ['Fimasartan + Indapamide']}, {'name': 'Fimasartan + Indapamide placebo', 'type': 'DRUG', 'otherNames': ['I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4'], 'description': 'a fixed dose combination', 'armGroupLabels': ['Fimasartan + Indapamide placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14647', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Bucheon St.Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}