Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-02 @ 2:49 PM
Study NCT ID:
NCT03210532
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'C548840', 'term': 'telmisartan amlodipine combination'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2017-07-04', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline', 'timeFrame': '8-week'}, {'measure': 'Change of LDL-C(Low Density Lipid Cholesterol) from baseline', 'timeFrame': '8-week'}]}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults both male and female who are ≥19,\\<80 years old\n* at screening, 140mmHg≤ SBP\\<180mmHg \\& 90mmHg≤ DBP\\<110mmHg \\& LDL-C≤250mg/dL \\& triglyceride\\<400mg/dL\n\nExclusion Criteria:\n\n* at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg\n* secondary hypertension or secondary dyslipidemia\n* patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease\n* women who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT03210532', 'briefTitle': 'Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'DW1501-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)', 'interventionNames': ['Drug: Telmisartan + Amlodipine + Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference 1', 'description': 'qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)', 'interventionNames': ['Drug: Telmisartan + Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference 2', 'description': 'qd PO,Twynsta(telmisartan/amlodipine)', 'interventionNames': ['Drug: Telmisartan + Amlodipine']}], 'interventions': [{'name': 'Telmisartan + Amlodipine + Rosuvastatin', 'type': 'DRUG', 'description': 'Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo', 'armGroupLabels': ['Test']}, {'name': 'Telmisartan + Amlodipine', 'type': 'DRUG', 'description': 'Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo', 'armGroupLabels': ['Reference 2']}, {'name': 'Telmisartan + Rosuvastatin', 'type': 'DRUG', 'description': 'Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo', 'armGroupLabels': ['Reference 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sevrance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}