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Completed

NCT Number: NCT06683768

A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Initial prescription of two or more antihypertensive medicines either with or without SPCs at the index date.
  • 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.
  • 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.
  • Pregnant women at any timepoint.

Treatment and study plan

Primary outcomes

  1. Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE

    Time frame: Week 8 and Week 24

  2. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE

    Time frame: Week 8 and Week 24

  3. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE

    Time frame: 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 outcomes

  1. Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category

    Time frame: Week 24

    BP Categories included Grade I, II, III, and (isolated) systolic hypertension.

  2. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category

    Time frame: Week 24

    BP Categories included Grade I, II, III, and (isolated) systolic hypertension.

  3. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category

    Time frame: 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.

  4. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category

    Time frame: Week 24

    Age group categories:

    • Less than 65 years old
    • 65 to 74 years old
    • 75 years or older

  5. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category

    Time frame: Week 24

    Age group categories:

    • Less than 65 years old
    • 65 to 74 years old
    • 75 years or older

  6. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category

    Time frame: 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.

  7. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category

    Time frame: Week 24

    BMI categories:

    • BMI <18.5
    • 18.5 ≤ BMI <25
    • 25 ≤ BMI

  8. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category

    Time frame: Week 24

    BMI categories:

    • BMI <18.5
    • 18.5 ≤ BMI <25
    • 25 ≤ BMI

  9. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category

    Time frame: 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.

  10. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category

    Time frame: Week 24

    eGFR categories:

    • eGFR <30
    • 30 ≤ eGFR <60
    • 60 ≤ eGFR

  11. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category

    Time frame: Week 24

    eGFR categories:

    • eGFR <30
    • 30 ≤ eGFR <60
    • 60 ≤ eGFR

  12. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category

    Time frame: 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.

  13. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level

    Time frame: Week 24

    Potassium (K) levels:

    • K <3.5
    • 3.5 ≤ K <5.5
    • 5.5 ≤ K

  14. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level

    Time frame: Week 24

    Potassium (K) levels:

    • K <3.5
    • 3.5 ≤ K <5.5
    • 5.5 ≤ K

  15. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level

    Time frame: 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.

  16. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level

    Time frame: Week 24

    Creatinine (Cr) Levels:

    • Cr <1.5
    • 1.5 ≤ Cr

  17. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level

    Time frame: Week 24

    Creatinine (Cr) Levels:

    • Cr <1.5
    • 1.5 ≤ Cr

  18. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level

    Time frame: 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.

  19. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria

    Time frame: Week 24

    Proteinuria:

    • Urine protein <30: Negative
    • 30 ≤ Protein urine: Positive

  20. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria

    Time frame: Week 24

    Proteinuria:

    • Urine protein <30: Negative
    • 30 ≤ Protein urine: Positive

  21. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria

    Time frame: 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.

  22. Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication

    Time frame: Week 24

    Antihypertensive medication classes included calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and diuretics.

  23. Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication

    Time frame: Week 24

    Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics.

  24. Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication

    Time frame: 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.

  25. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12

    Time frame: Weeks 4, 8, and 12

  26. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category

    Time frame: Weeks 4, 8, and 12

    BP categories included Grade I, II, and III hypertension.

  27. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category

    Time frame: Weeks 4, 8, and 12

    Age group categories:

    • Less than 65 years old
    • 65 to 74 years old
    • 75 years or older

  28. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category

    Time frame: Weeks 4, 8, and 12

    BMI categories:

    • BMI <18.5
    • 18.5 ≤ BMI <25
    • 25 ≤ BMI

  29. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category

    Time frame: Weeks 4, 8, and 12

    eGFR categories:

    • eGFR <30
    • 30 ≤ eGFR <60
    • 60 ≤ eGFR

  30. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level

    Time frame: Weeks 4, 8, and 12

    Potassium (K) levels:

    • K <3.5
    • 3.5 ≤ K <5.5
    • 5.5 ≤ K

  31. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level

    Time frame: Weeks 4, 8, and 12

    Creatinine (Cr) Levels:

    • Cr <1.5
    • 1.5 ≤ Cr

  32. Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria

    Time frame: Weeks 4, 8, and 12

    Proteinuria:

    • Urine protein <30: Negative
    • 30 ≤ Protein urine: Positive

  33. Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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