Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-04-24 @ 9:01 PM
Study NCT ID:
NCT02955368
Status:
WITHDRAWN
Last Update Posted:
2017-06-05
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of DP-R212
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Canceled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change of LDL-Cholesterol', 'timeFrame': '0, 8 weeks'}, {'measure': 'Change of mean seated Systolic Blood Pressure', 'timeFrame': '0, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DP-R212'], 'conditions': ['Hypertension', 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both man and woman who is over 19 years old\n* Hypertension patient with hypercholesterolemia\n\nExclusion Criteria:\n\n* sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg\n* A history of cardiovascular disease\n* rhabdomyolysis, myopathy\n* Hypertension or hypercholesterolemia due to secondary causes\n* Uncontrolled diabetes\n* Evidence of hepatic or renal disease'}, 'identificationModule': {'nctId': 'NCT02955368', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of DP-R212', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvogen Korea'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension', 'orgStudyIdInfo': {'id': 'DP-CTR212-III-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DP-R212 group', 'description': 'DP-R212 + C1-R212 placebo + C2-R212 placebo', 'interventionNames': ['Drug: DP-R212']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C1-R212 group', 'description': 'DP-R212 placebo + C1-R212 + C2-R212 placebo', 'interventionNames': ['Drug: C1-R212']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C2-R212 group', 'description': 'DP-R212 placebo + C1-R212 placebo + C2-R212', 'interventionNames': ['Drug: C2-R212']}], 'interventions': [{'name': 'DP-R212', 'type': 'DRUG', 'description': 'DP-R212 + C1-R212 placebo + C2-R212 placebo', 'armGroupLabels': ['DP-R212 group']}, {'name': 'C1-R212', 'type': 'DRUG', 'description': 'DP-R212 placebo + C1-R212 + C2-R212 placebo', 'armGroupLabels': ['C1-R212 group']}, {'name': 'C2-R212', 'type': 'DRUG', 'description': 'DP-R212 placebo + C1-R212 placebo + C2-R212', 'armGroupLabels': ['C2-R212 group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvogen Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}