Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01122251
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2010-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060343', 'term': 'lercanidipine'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-17', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-12', 'lastUpdatePostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sitDBP', 'timeFrame': 'Baseline, Week 8', 'description': 'Average changes from baseline in sitDBP'}], 'secondaryOutcomes': [{'measure': 'sitDBP', 'timeFrame': 'Week 4, 8', 'description': 'Response rates (proportion of patients sitDBP\\<90mmHg or ≥10-mmHg reduction from baseline)'}, {'measure': 'sitDBP', 'timeFrame': 'Week 4', 'description': 'Average changes from baselin in sitDBP'}, {'measure': 'sitSBP', 'timeFrame': 'Week 4, 8', 'description': 'Average changes from baselini in sitSBP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'lercanidipine', 'valsartan'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/highbloodpressure.html', 'label': 'High Blood Pressure'}, {'url': 'http://www.mims.co.uk/Drugs/cardiovascular-system/hypertension/zanidip/', 'label': 'Lercanidipine'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0137862534&QV1=VALSARTAN', 'label': 'Valsartan'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 20 and 75\n* Essential hypertension at screening (-3 week)\n\nRandomization Criteria:\n\n* Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)\n\nExclusion Criteria:\n\n* Mean sitDBP≥110mmHg or sitSBP≥180\n* Secondary hypertension or suspected secondary hypertension\n* Uncontrolled diabetes\n* Severe heart disease or severe cerebrovascular disease\n* clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)\n* History of malignant disease\n* Autoimmune disease\n* Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial'}, 'identificationModule': {'nctId': 'NCT01122251', 'briefTitle': 'Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'LG-ZVCL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lercanidpine + Valsartan', 'description': 'L10/V80, L20/V80, L10/V160, L20/V160', 'interventionNames': ['Drug: Lercanidipine + Valsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lercanidipine or Valsartan', 'description': 'L10, L20, V80, V160', 'interventionNames': ['Drug: Lercanidipine or Valsartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparators of Lercanidipine and Valsartan', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lercanidipine + Valsartan', 'type': 'DRUG', 'description': 'L10/V80, L20/V80, L10/V160, L20/V160', 'armGroupLabels': ['Lercanidpine + Valsartan']}, {'name': 'Lercanidipine or Valsartan', 'type': 'DRUG', 'description': 'L10, L20, V80, V160', 'armGroupLabels': ['Lercanidipine or Valsartan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of Lercanidipine and Valsartan', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul, Busan Etc.', 'country': 'South Korea', 'facility': '23 sites in Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kim, Sung Il / Assistant Manager', 'oldOrganization': 'Clinical Trial 1 Team'}}}}