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A Phase 2 Exploratory Study to evaluate efficacy and safety of CS-3150 in Japanese Hypertensive Patients with Moderate Kidney Dysfunction

A Phase 2 Exploratory Study to evaluate efficacy and safety of CS-3150 in Japanese Hypertensive Patients with Moderate Kidney Dysfunction

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222831
Enrollment
30
Registered
2015-04-24
Start date
2015-05-23
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 with moderate kidney dysfunction

Interventions

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Male and female subjects aged 20 years or older and 80 years or younger at informed consent 2)Subjects with hypertension (Sitting SBP >= 140 mmHg and = 80 mmHg and = 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2

Exclusion criteria

Exclusion criteria: 1)Secondary hypertension (except renoparenchymal hypertension) or malignant hypertension 2)Diabetes mellitus with albuminuria 3)Serum potassium level = 5.1 mEq/L 4)Subjects under Insulin treatment 5)Subjects under or pre-planned for hemodialysis

Design outcomes

Primary

MeasureTime frame
safety efficacy - Change from baseline in sitting systolic and diastolic blood pressure - Adverse events

Secondary

MeasureTime frame
safety efficacy - Time course of sitting systolic and diastolic blood pressure - Proportion of patients achieving sitting blood pressure control - Change from baseline in urinary albumin creatinine ratio - Change in serum potassium

Countries

Japan

Outcome results

None listed

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