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

NCT ID: NCT06683768

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40563 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2023-11-08

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Monotherapy Cohort

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

No interventions assigned to this group

Single-pill Combination (SPC) Cohort

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CLCZ696AJP03

Identifier Type: -

Identifier Source: org_study_id