Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria

A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02807974

Enrollment

Registered

2016-06-21

Start date

2016-06-30

Completion date

2017-03-31

Last updated

2018-12-21

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

Conditions

Hypertension

Keywords

Hypertension with Type 2 Diabetes and Albuminuria, Diabetic nephropathy, Diabetic renal disease, Albuminuria, Mineralocorticoid receptor antagonist

Brief summary

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.

Interventions

DRUGCS-3150

CS-3150 1.25 to 2.5, 5mg, orally

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

* Male and female subjects aged 20 to 80 years at informed consent * Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, \< 1000 mg/g/Cr) * Subjects with hypertension (Sitting SBP ≥ 140 mmHg, \<180 mmHg and Sitting DBP ≥ 80 mmHg, \<110 mmHg * Treatment with an ARB or ACE inhibitor * eGFR ≥ 30 mL/min/1.73m\^2

Exclusion criteria

* Secondary hypertension or malignant hypertension * Type 1 diabetes * Secondary glucose intolerance * Diagnosed with non-diabetic nephropathy * Serum potassium level \< 3.5 or ≥ 4.8 mEq/L

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Time course of systolic and diastolic blood pressure	Baseline to end of Week 12	Time course of systolic and diastolic blood pressure
Proportion of patients achieving blood pressure control	Baseline to end of Week 12	Proportion of patients achieving blood pressure control
Change rate from baseline in urine-albumin-to-creatinine ratio	Baseline to end of Week 12	Change rate from baseline in urine-albumin-to-creatinine ratio.
Time course of urine-albumin-to-creatinine ratio	Baseline to end of Week 12	Time course of urine-albumin-to-creatinine ratio.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026