A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment

A Multi-center, Open Label, Dose Titration, Exploratory Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02448628

Enrollment

Registered

2015-05-19

Start date

2015-05-31

Completion date

2015-12-31

Last updated

2019-10-08

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

Conditions

Hypertension

Keywords

Hypertension, moderate renal impairment, mineralocorticoid receptor antagonist, CS-3150, Japanese

Brief summary

This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Interventions

DRUGCS-3150

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Men and women Aged 20 years or older and 80 years or younger at informed consent * Subjects with hypertension (Sitting systolic blood pressure SBP \>= 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP \>= 80 mmHg and \< 110 mmHg) * estimated glomerular filtration rate eGFR \>= 30 mL/min/1.73 m2 and \< 60 mL/min/1.73 m2

Exclusion criteria

* Secondary hypertension or malignant hypertension * Diabetes mellitus with albuminuria * Serum potassium level \< 3.5 or \>= 5.1 mEq/L * Subjects under Insulin treatment * Subjects under or pre-planned for hemodialysis

Design outcomes

Primary

Measure	Time frame
Change from baseline in sitting systolic and diastolic blood pressure	Baseline to end of Week 12

Secondary

Measure	Time frame	Description
Change from baseline in UACR	Baseline to end of Week 12	Urine Albumin Creatinine Ratio (UACR)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026