A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT06683768
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40563
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE Week 8 and Week 24 Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE Week 8 and Week 24 Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE Week 8 and Week 24 Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
- Secondary Outcome Measures
Name Time Method Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category Week 24 BP Categories included Grade I, II, III, and (isolated) systolic hypertension.
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category Week 24 BP Categories included Grade I, II, III, and (isolated) systolic hypertension.
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category Week 24 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.
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category Week 24 Age group categories:
* Less than 65 years old
* 65 to 74 years old
* 75 years or olderNumber of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category Week 24 Age group categories:
* Less than 65 years old
* 65 to 74 years old
* 75 years or olderIncidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category Week 24 Age group categories:
* Less than 65 years old
* 65 to 74 years old
* 75 years or older
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category Week 24 BMI categories:
* BMI \<18.5
* 18.5 ≤ BMI \<25
* 25 ≤ BMINumber of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category Week 24 BMI categories:
* BMI \<18.5
* 18.5 ≤ BMI \<25
* 25 ≤ BMIIncidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category Week 24 BMI categories:
* BMI \<18.5
* 18.5 ≤ BMI \<25
* 25 ≤ BMI
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category Week 24 eGFR categories:
* eGFR \<30
* 30 ≤ eGFR \<60
* 60 ≤ eGFRNumber of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category Week 24 eGFR categories:
* eGFR \<30
* 30 ≤ eGFR \<60
* 60 ≤ eGFRIncidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category Week 24 eGFR categories:
* eGFR \<30
* 30 ≤ eGFR \<60
* 60 ≤ eGFR
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level Week 24 Potassium (K) levels:
* K \<3.5
* 3.5 ≤ K \<5.5
* 5.5 ≤ KNumber of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level Week 24 Potassium (K) levels:
* K \<3.5
* 3.5 ≤ K \<5.5
* 5.5 ≤ KIncidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level Week 24 Potassium (K) levels:
* K \<3.5
* 3.5 ≤ K \<5.5
* 5.5 ≤ K
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level Week 24 Creatinine (Cr) Levels:
* Cr \<1.5
* 1.5 ≤ CrNumber of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level Week 24 Creatinine (Cr) Levels:
* Cr \<1.5
* 1.5 ≤ CrIncidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level Week 24 Creatinine (Cr) Levels:
* Cr \<1.5
* 1.5 ≤ Cr
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria Week 24 Proteinuria:
* Urine protein \<30: Negative
* 30 ≤ Protein urine: PositiveNumber of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria Week 24 Proteinuria:
* Urine protein \<30: Negative
* 30 ≤ Protein urine: PositiveIncidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria Week 24 Proteinuria:
* Urine protein \<30: Negative
* 30 ≤ Protein urine: Positive
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication Week 24 Antihypertensive medication classes included calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and diuretics.
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication Week 24 Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics.
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication Week 24 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.
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 Weeks 4, 8, and 12 Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category Weeks 4, 8, and 12 BP categories included Grade I, II, and III hypertension.
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category Weeks 4, 8, and 12 Age group categories:
* Less than 65 years old
* 65 to 74 years old
* 75 years or olderChange in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category Weeks 4, 8, and 12 BMI categories:
* BMI \<18.5
* 18.5 ≤ BMI \<25
* 25 ≤ BMIChange in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category Weeks 4, 8, and 12 eGFR categories:
* eGFR \<30
* 30 ≤ eGFR \<60
* 60 ≤ eGFRChange in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level Weeks 4, 8, and 12 Potassium (K) levels:
* K \<3.5
* 3.5 ≤ K \<5.5
* 5.5 ≤ KChange in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level Weeks 4, 8, and 12 Creatinine (Cr) Levels:
* Cr \<1.5
* 1.5 ≤ CrChange in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria Weeks 4, 8, and 12 Proteinuria:
* Urine protein \<30: Negative
* 30 ≤ Protein urine: PositiveNumber of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup Up to 13 weeks The BP goal was 130/80 millimeters of mercury (mm Hg).
Subgroups:
* BP Grade
* Age
* BMI
* Estimated glomerular filtration rate (eGFR)
* Potassium Level
* Creatinine Level
* Proteinuria (positive or negative)
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States