Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-02-01 @ 3:34 AM
Study NCT ID:
NCT02770261
Status:
COMPLETED
Last Update Posted:
2016-12-26
First Post:
2016-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-23', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol', 'timeFrame': '8weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DP-R208'], 'conditions': ['Hypertension', 'Cholesterolemia']}, 'referencesModule': {'references': [{'pmid': '31307833', 'type': 'DERIVED', 'citation': 'Cho KI, Kim BH, Park YH, Ahn JC, Kim SH, Chung WJ, Kim W, Sohn IS, Shin JH, Kim YJ, Chang K, Yu CW, Ahn SH, Kim SY, Ryu JK, Lee JY, Hong BK, Hong TJ, Gyu Park C. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. Clin Ther. 2019 Aug;41(8):1508-1521. doi: 10.1016/j.clinthera.2019.05.007. Epub 2019 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine superiority of DP-R208 compare 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 19years old.\n* Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL\n\nExclusion Criteria:\n\n* Therapeutic lifestylechange is not enought during the study period\n* SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit'}, 'identificationModule': {'nctId': 'NCT02770261', 'briefTitle': 'Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvogen Korea'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.', 'orgStudyIdInfo': {'id': 'DP-CTR208-III-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CR group', 'description': 'DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla', 'interventionNames': ['Drug: DP-R208', 'Drug: Candesartan32mg Placebo', 'Drug: Rosuvastatin 20mg Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CP group', 'description': 'DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla', 'interventionNames': ['Drug: Candesartan32mg', 'Drug: DP-R208 Placebo', 'Drug: Rosuvastatin 20mg Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PR group', 'description': 'DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg', 'interventionNames': ['Drug: Rosuvastatin 20mg', 'Drug: DP-R208 Placebo', 'Drug: Candesartan32mg Placebo']}], 'interventions': [{'name': 'DP-R208', 'type': 'DRUG', 'description': 'DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo', 'armGroupLabels': ['CR group']}, {'name': 'Candesartan32mg', 'type': 'DRUG', 'otherNames': ['Candesartan'], 'description': 'DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo', 'armGroupLabels': ['CP group']}, {'name': 'Rosuvastatin 20mg', 'type': 'DRUG', 'otherNames': ['Rosuvastatin'], 'description': 'DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg', 'armGroupLabels': ['PR group']}, {'name': 'DP-R208 Placebo', 'type': 'DRUG', 'description': 'DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg', 'armGroupLabels': ['CP group', 'PR group']}, {'name': 'Candesartan32mg Placebo', 'type': 'DRUG', 'description': 'DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg', 'armGroupLabels': ['CR group', 'PR group']}, {'name': 'Rosuvastatin 20mg Placebo', 'type': 'DRUG', 'description': 'DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo', 'armGroupLabels': ['CP group', 'CR group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Changkyu Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvogen Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}