Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 5:49 PM
Study NCT ID:
NCT01828359
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2013-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With 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': 'D017311', 'term': 'Amlodipine'}, {'id': 'D019808', 'term': 'Losartan'}, {'id': 'D011392', 'term': 'Proline'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2013-04-07', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)', 'timeFrame': 'Baseline, Week 8'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in MSDBP', 'timeFrame': 'Baseline, week 4'}, {'measure': 'Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)', 'timeFrame': 'Baseline, Week 4 and 8'}, {'measure': 'Blood pressure responder rate', 'timeFrame': 'Baseline, Week 4 and 8', 'description': 'Rate of patients who achieved target blood pressure (MSSBP \\< 140 mmHg and MSDBP \\< 90 mmHg), or MSSBP decrease \\> 20 mmHg from baseline or MSDBP decrease \\> 10 mmHg from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.', 'detailedDescription': '* Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).\n* Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.\n* Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 aged or over\n* Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs\n* Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)\n\nExclusion Criteria:\n\n* Patients with too high Blood pressure\n\n •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening\n* History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.\n* Secondary hypertension or suspected to be'}, 'identificationModule': {'nctId': 'NCT01828359', 'briefTitle': 'The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy', 'orgStudyIdInfo': {'id': 'HM-ALOS-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amosartan® tab', 'description': 'Amlodipine 5mg /Losartan 100mg', 'interventionNames': ['Drug: Amosartan® tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cozaar® plus pro tab', 'description': 'Losartan 100mg/ HCTZ 12.5mg', 'interventionNames': ['Drug: Cozaar® plus pro tab']}], 'interventions': [{'name': 'Amosartan® tab', 'type': 'DRUG', 'otherNames': ['Amlodipine 5mg /Losartan 100mg'], 'description': 'comparison of different combination of anti-hypertension drug', 'armGroupLabels': ['Amosartan® tab']}, {'name': 'Cozaar® plus pro tab', 'type': 'DRUG', 'otherNames': ['Losartan 100mg/ HCTZ 12.5mg'], 'description': 'comparison of different combination of anti-hypertension drug', 'armGroupLabels': ['Cozaar® plus pro tab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Taehoon Ahn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}