Skip to content

Survey on the occurrence of hyperkalemia after administration of MINNEBRO tablets in patients with hypertension -MID-NET Cohort Study-

Survey on the occurrence of hyperkalemia after administration of MINNEBRO tablets in patients with hypertension -MID-NET Cohort Study-

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT2031210423
Enrollment
1600
Registered
2021-11-12
Start date
2009-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

None listed

Sponsors

Matsuoka Yomei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The diagnostic of hypertension exists during the enrollment period (May 1, 2019 to May 31, 2023). 2) MINNEBRO tablets or eplerenone has been prescribed during the enrollment period. The earliest prescription date of this drug or eplerenone during the enrollment period is the cohort entry date. 3) The diagnosis of hypertension exists from 30 days before the cohort entry date to the cohort entry date. 4) The earliest medical record date after the data period start date is more than 180 days before the cohort entry date.

Exclusion criteria

Exclusion criteria: 1) The prescription period of eplerenone is included for at least one day between 180 days before the cohort entry date and the cohort entry date. 2) Serum potassium levels have never been measured during the follow-up period. 3) Serum potassium levels have never been measured between 120 days before the cohort entry date and the cohort entry date. 4) Between 120 days before the cohort entry date and the cohort entry date, the serum potassium value on the measurement date closest to the cohort entry date exceeds 5.0 mEq / L. 5) Between 120 days before the cohort entry date and the cohort entry date, the eGFR on the measurement date closest to the cohort entry date is less than 60 mL/min/1.73 m2. 6) The prescription period of the following drugs includes the start date of the follow-up period. i) potassium sparing diuretic (spironolactone, triamterene and potassium canrenoate) ii) potassium preparations (potassium chloride, potassium gluconate, potassium aspartate, potassium iodide and potassium acetate) iii) itraconazole, ritonavir, and nelfinavir 7) Between 180 days before the cohort entry date and the cohort entry date, there is severe hepatic dysfunction. 8) Between 180 days before the cohort entry date and the cohort entry date, there is diabetes mellitus with albuminuria or proteinuria.

Design outcomes

Primary

MeasureTime frame
Development of hyperkalemia

Contacts

Public ContactContact GPSP

Daiichi Sankyo Co.,Ltd.

contact_gpsp@daiichisankyo.co.jp+81-3-6225-1059

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026