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

NCT ID: NCT02807987

Last Updated: 2018-12-21

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.

Detailed Description

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Conditions

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Hypertension With Moderate Renal Impairment

Keywords

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Mineralocorticoid receptor antagonist Moderate renal impairment 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 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

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo Co., Ltd.

Locations

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Nagano, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CS3150-A-J305

Identifier Type: -

Identifier Source: org_study_id