Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

Hypertension With Moderate Renal Impairment Clinical Trial

Official title:

A Study of CS-3150 to Evaluate Efficacy and Safety in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807987
• Other study ID #: CS3150-A-J305
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: May 15, 2017

Study information

• Verified date: August 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 moderate renal impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female subjects aged 20 or order to 80 or younger years at informed consent

• 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/1.73 m2 and < 60 mL/min/1.73 m2

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• Diabetes mellitus with albuminuria

• Subjects under Insulin treatment

• Subjects under or pre-planned for hemodialysis

• Serum potassium level < 3.5 or = 4.8 mEq/L

Related Conditions & MeSH terms

• Hypertension
• Hypertension With Moderate Renal Impairment
• Renal Insufficiency

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