A Phase 2 Exploratory Study of CS-3150 in Japanese 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

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

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This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

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Detailed Description

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Conditions

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Hypertension

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 5.0 mg , orally, once daily after breakfast for 12 weeks

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

Interventions

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CS-3150

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women Aged 20 years or older and 80 years or younger at informed consent
* Subjects with hypertension (Sitting systolic blood pressure SBP \>= 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP \>= 80 mmHg and \< 110 mmHg)
* estimated glomerular filtration rate 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
* Serum potassium level \< 3.5 or \>= 5.1 mEq/L
* Subjects under Insulin treatment
* Subjects under or pre-planned for hemodialysis

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No