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

NCT06683768 | Completed

• 1 other identifier: CLCZ696AJP03
• Study Type: observational
• Target: 40,563
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Essential hypertension; High blood pressure

Outcome Measures

Primary Outcomes (3)

• 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

  Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.

  Week 8 and Week 24

Secondary Outcomes (33)

• 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

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

  Week 24

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

  Week 24

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

  Week 24

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

  Week 24

Study Arms (2)

Monotherapy Cohort

Adult patients with untreated hypertension who initiated antihypertensive monotherapy (excluding angiotensin receptor neprilysin inhibitor \[ARNI\]).

Single-pill Combination (SPC) Cohort

Adult patients with untreated hypertension who initiated single-pill combination antihypertensive therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: February 28, 2023
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (1)