Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-24 @ 9:23 PM
Study NCT ID:
NCT02415192
Status:
UNKNOWN
Last Update Posted:
2016-04-19
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}], 'ancestors': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'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'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2001}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.', 'timeFrame': '6month'}], 'secondaryOutcomes': [{'measure': 'mean change of the blood pressure and pulse after administation of drug at 12week and 24week.', 'timeFrame': '12weeks, 24weeks'}, {'measure': 'BP control rate', 'timeFrame': '12weeks, 24weeks'}, {'measure': 'Responder rate', 'timeFrame': '12weeks, 24weeks'}, {'measure': 'Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available', 'timeFrame': '12weeks, 24weeks'}, {'measure': 'Evaluation of cardiovascular risk', 'timeFrame': '12weeks, 24weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety data', 'hypertension therapy'], 'conditions': ['Lower Leg Edema', 'Orthostatic Hypertension']}, 'descriptionModule': {'briefSummary': "Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus, there's no enough safety data and efficacy data defined from the clinical study.\n\nAlso, many combination drugs of valsartaa and amlodipine are widely used in the market.\n\nLGLS will compare the safety(adverse events especially the lower leg edema) and efficacy (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with essential hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients aged over 19 with essential hypertension\n* Those who meet the inclusion criteria, fall under any of the following 3 cases and determined by the investigator to be prescribed Levacalm or Valsartan/Amlodipine combination:\n\n 1. those who can't maintain the blood pressure with the antihypertensive drug before.\n 2. those who diagnosed to a hypertension stage 2.(DBP is higher than 160mmHg or SBP is higher than 100mmHg)\n 3. those who fall under the following :cardiovascular disease, Cerebrovascular disease, chronic Renal disease, diabetes mellitus, peripheral vascular disease\n* Those who were informed of the purpose, method, and effect etc. of this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Those who are included in the contraindication of study drug following the information for use of the product\n2. Those who is/will be participated in other drug clinical trial\n3. Those who adminitrated other antihypertensive drugs beside the levacalm or Valsartan/amlodipine combination drug.\n4. Those who judged by the invesigator as ineligible for this clinical study"}, 'identificationModule': {'nctId': 'NCT02415192', 'briefTitle': 'Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension', 'orgStudyIdInfo': {'id': 'LG-ZVOS001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with Levacalm', 'description': 'In this group, the patients will be enrolled treated with Levacalm tab. as an anti-hypertensive drug.\n\nThe number of this group will be double than the control group to get more information about safety and efficacy.', 'interventionNames': ['Drug: Levacalm']}, {'label': 'Patients treated with Valsartan/amlodipine', 'description': 'In this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug.', 'interventionNames': ['Drug: Valsartan/amlodipine']}], 'interventions': [{'name': 'Levacalm', 'type': 'DRUG', 'armGroupLabels': ['Patients treated with Levacalm']}, {'name': 'Valsartan/amlodipine', 'type': 'DRUG', 'armGroupLabels': ['Patients treated with Valsartan/amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-783', 'city': 'Seoul', 'state': 'Jongno gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hye jin Yoon', 'role': 'CONTACT'}], 'facility': 'LG Life Science', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hye Jin Yoon', 'role': 'CONTACT', 'email': 'hyejin0611@lgls.com', 'phone': '82-2-6924-3148'}], 'overallOfficials': [{'name': 'Keun Soo Bang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LG Life Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}