Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-03-09 @ 2:44 PM
Study NCT ID:
NCT01764295
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2013-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study for Patients With Hypertension Associated With 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': 'C437965', 'term': 'olmesartan'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2013-01-07', 'studyFirstSubmitQcDate': '2013-01-08', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C percent change of DWJ1276 from baseline', 'timeFrame': '8weeks'}, {'measure': 'DBP change of DWJ1276 from baseline', 'timeFrame': '8weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline', 'timeFrame': '8weeks'}, {'measure': 'Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report', 'timeFrame': '8weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of DWJ1276'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female in between ages of 20 and 80 at the time of screening\n* Subject who can understand information provided and who can sign written consent voluntarily\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to olmesartan and rosuvastatin\n* Pregnant or lactating women and fertile women who is not using proper contraceptive method\n* Patient with history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01764295', 'briefTitle': 'Clinical Study for Patients With Hypertension Associated With Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia', 'orgStudyIdInfo': {'id': 'DW_DWJ1276003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWJ1276', 'description': 'Once daily, administered orally, 8 week', 'interventionNames': ['Drug: DWJ1276']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olmesartan', 'description': 'Once daily, administered orally, 8 week', 'interventionNames': ['Drug: Olmesartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'Once daily, administered orally, 8 week', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once daily, administered orally, 8 week', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DWJ1276', 'type': 'DRUG', 'armGroupLabels': ['DWJ1276']}, {'name': 'Olmesartan', 'type': 'DRUG', 'armGroupLabels': ['Olmesartan']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}