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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: CS-3150

• Registration Number: NCT02807974
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-21
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS-3150	CS-3150	CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time course of urine-albumin-to-creatinine ratio	Baseline to end of Week 12	Time course of urine-albumin-to-creatinine ratio.
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 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