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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807974
• Other study ID #: CS3150-A-J306
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Drug:
• CS-3150
CS-3150 1.25 to 2.5, 5mg, orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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