Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 10:33 AM
Study NCT ID:
NCT06683768
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2024-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40563}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-08', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE', 'timeFrame': 'Week 8 and Week 24'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE', 'timeFrame': 'Week 8 and Week 24'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE', 'timeFrame': 'Week 8 and Week 24', 'description': 'Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category', 'timeFrame': 'Week 24', 'description': 'BP Categories included Grade I, II, III, and (isolated) systolic hypertension.'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category', 'timeFrame': 'Week 24', 'description': 'BP Categories included Grade I, II, III, and (isolated) systolic hypertension.'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category', 'timeFrame': 'Week 24', 'description': 'BP Categories included Grade I, II, III, and (isolated) systolic hypertension. Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category', 'timeFrame': 'Week 24', 'description': 'Age group categories:\n\n* Less than 65 years old\n* 65 to 74 years old\n* 75 years or older'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category', 'timeFrame': 'Week 24', 'description': 'Age group categories:\n\n* Less than 65 years old\n* 65 to 74 years old\n* 75 years or older'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category', 'timeFrame': 'Week 24', 'description': 'Age group categories:\n\n* Less than 65 years old\n* 65 to 74 years old\n* 75 years or older\n\nIncidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category', 'timeFrame': 'Week 24', 'description': 'BMI categories:\n\n* BMI \\<18.5\n* 18.5 ≤ BMI \\<25\n* 25 ≤ BMI'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category', 'timeFrame': 'Week 24', 'description': 'BMI categories:\n\n* BMI \\<18.5\n* 18.5 ≤ BMI \\<25\n* 25 ≤ BMI'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category', 'timeFrame': 'Week 24', 'description': 'BMI categories:\n\n* BMI \\<18.5\n* 18.5 ≤ BMI \\<25\n* 25 ≤ BMI\n\nIncidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category', 'timeFrame': 'Week 24', 'description': 'eGFR categories:\n\n* eGFR \\<30\n* 30 ≤ eGFR \\<60\n* 60 ≤ eGFR'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category', 'timeFrame': 'Week 24', 'description': 'eGFR categories:\n\n* eGFR \\<30\n* 30 ≤ eGFR \\<60\n* 60 ≤ eGFR'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category', 'timeFrame': 'Week 24', 'description': 'eGFR categories:\n\n* eGFR \\<30\n* 30 ≤ eGFR \\<60\n* 60 ≤ eGFR\n\nIncidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level', 'timeFrame': 'Week 24', 'description': 'Potassium (K) levels:\n\n* K \\<3.5\n* 3.5 ≤ K \\<5.5\n* 5.5 ≤ K'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level', 'timeFrame': 'Week 24', 'description': 'Potassium (K) levels:\n\n* K \\<3.5\n* 3.5 ≤ K \\<5.5\n* 5.5 ≤ K'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level', 'timeFrame': 'Week 24', 'description': 'Potassium (K) levels:\n\n* K \\<3.5\n* 3.5 ≤ K \\<5.5\n* 5.5 ≤ K\n\nIncidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level', 'timeFrame': 'Week 24', 'description': 'Creatinine (Cr) Levels:\n\n* Cr \\<1.5\n* 1.5 ≤ Cr'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level', 'timeFrame': 'Week 24', 'description': 'Creatinine (Cr) Levels:\n\n* Cr \\<1.5\n* 1.5 ≤ Cr'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level', 'timeFrame': 'Week 24', 'description': 'Creatinine (Cr) Levels:\n\n* Cr \\<1.5\n* 1.5 ≤ Cr\n\nIncidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria', 'timeFrame': 'Week 24', 'description': 'Proteinuria:\n\n* Urine protein \\<30: Negative\n* 30 ≤ Protein urine: Positive'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria', 'timeFrame': 'Week 24', 'description': 'Proteinuria:\n\n* Urine protein \\<30: Negative\n* 30 ≤ Protein urine: Positive'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria', 'timeFrame': 'Week 24', 'description': 'Proteinuria:\n\n* Urine protein \\<30: Negative\n* 30 ≤ Protein urine: Positive\n\nIncidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication', 'timeFrame': 'Week 24', 'description': 'Antihypertensive medication classes included calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and diuretics.'}, {'measure': 'Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication', 'timeFrame': 'Week 24', 'description': 'Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics.'}, {'measure': 'Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication', 'timeFrame': 'Week 24', 'description': 'Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics. Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12', 'timeFrame': 'Weeks 4, 8, and 12'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'BP categories included Grade I, II, and III hypertension.'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'Age group categories:\n\n* Less than 65 years old\n* 65 to 74 years old\n* 75 years or older'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'BMI categories:\n\n* BMI \\<18.5\n* 18.5 ≤ BMI \\<25\n* 25 ≤ BMI'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'eGFR categories:\n\n* eGFR \\<30\n* 30 ≤ eGFR \\<60\n* 60 ≤ eGFR'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'Potassium (K) levels:\n\n* K \\<3.5\n* 3.5 ≤ K \\<5.5\n* 5.5 ≤ K'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'Creatinine (Cr) Levels:\n\n* Cr \\<1.5\n* 1.5 ≤ Cr'}, {'measure': 'Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'Proteinuria:\n\n* Urine protein \\<30: Negative\n* 30 ≤ Protein urine: Positive'}, {'measure': 'Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup', 'timeFrame': 'Up to 13 weeks', 'description': 'The BP goal was 130/80 millimeters of mercury (mm Hg).\n\nSubgroups:\n\n* BP Grade\n* Age\n* BMI\n* Estimated glomerular filtration rate (eGFR)\n* Potassium Level\n* Creatinine Level\n* Proteinuria (positive or negative)'}]}, 'conditionsModule': {'keywords': ['Essential hypertension', 'High blood pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This was a non-interventional, secondary use of data, retrospective, cohort study. The data extracted in this study was used as secondary use of collected patient information in the database, Japan Medical Data Survey (JAMDAS), owned by M3 Inc. (Tokyo, Japan). JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Diagnosed with essential hypertension or hypertensive heart/kidney disease at the index date.\n2. Sitting systolic blood pressure (sSBP) ≥150 millimeters of mercury (mm Hg) at the index date.\n3. At least one prescription of angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), calcium channel blocker (CCB), diuretics, or these SPCs for hypertension at the index date.\n4. At least one visit and blood pressure (BP) measurement within 12 weeks from the index date.\n\nExclusion criteria:\n\n1. Prescription of hypertensive medication including alpha blocker, beta blocker, alpha-beta blocker, aldosterone antagonist, and renin inhibitor within 24 weeks prior to the index date.\n2. Initial prescription of two or more antihypertensive medicines either with or without SPCs at the index date.\n3. History of hypotension, hyperkalemia, hypokalemia, or hyponatremia, drug-related or otherwise, or renal failure leading to dialysis, stroke, myocardial infarction, heart failure at the index date or within 24 weeks prior to the index date.\n4. History of secondary hypertension (renal parenchymal hypertension, renovascular hypertension \\[unilateral or bilateral renal artery stenosis\\] coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, etc.) at any timepoint.\n5. Pregnant women at any timepoint."}, 'identificationModule': {'nctId': 'NCT06683768', 'briefTitle': 'A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan', 'orgStudyIdInfo': {'id': 'CLCZ696AJP03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monotherapy Cohort', 'description': 'Adult patients with untreated hypertension who initiated antihypertensive monotherapy (excluding angiotensin receptor neprilysin inhibitor \\[ARNI\\]).'}, {'label': 'Single-pill Combination (SPC) Cohort', 'description': 'Adult patients with untreated hypertension who initiated single-pill combination antihypertensive therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}