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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-05-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension With Moderate Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CS-3150

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

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 1.25 to 2.5, 5mg, orally

Interventions

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CS-3150

CS-3150 1.25 to 2.5, 5mg, orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No