Clinical trial NCT06683768: A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension
Official title: Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Essential hypertension
High blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 40563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

1. Diagnosed with essential hypertension or hypertensive heart/kidney disease at the index date.
2. Sitting systolic blood pressure (sSBP) ≥150 millimeters of mercury (mm Hg) at the index date.
3. 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.
4. At least one visit and blood pressure (BP) measurement within 12 weeks from the index date.

Exclusion criteria:

1. 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.
2. Initial prescription of two or more antihypertensive medicines either with or without SPCs at the index date.
3. 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.
4. 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.
5. Pregnant women at any timepoint.

Primary outcomes:
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
Secondary outcomes:
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
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
measure: Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category
timeFrame: Week 24
measure: Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
timeFrame: Week 24
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
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
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
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
measure: Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category
timeFrame: Week 24
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
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
measure: Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category
timeFrame: Week 24
measure: Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
timeFrame: Week 24
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
measure: Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
timeFrame: Week 24
measure: Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
timeFrame: Week 24
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
measure: Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
timeFrame: Week 24
measure: Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
timeFrame: Week 24
measure: Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
timeFrame: Week 24
measure: Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
timeFrame: Week 24
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
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
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
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
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
measure: Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category
timeFrame: Weeks 4, 8, and 12
measure: Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category
timeFrame: Weeks 4, 8, and 12
measure: Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level
timeFrame: Weeks 4, 8, and 12
measure: Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level
timeFrame: Weeks 4, 8, and 12
measure: Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria
timeFrame: Weeks 4, 8, and 12
measure: Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: