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Study of CS-3150 in Patients With Primary Aldosteronism

NCT ID: NCT02885662

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

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-20

Brief Summary

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To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

Detailed Description

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Conditions

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Primary Aldosteronism

Keywords

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Primary aldosteronism Hypertension mineralocorticoid receptor antagonist Developmental Phase III

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 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 2.5 to 5.0 mg , orally.

Interventions

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CS-3150

CS-3150 2.5 to 5.0 mg , orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects aged 20 years or older at informed consent
* Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
* Patients satisfying following blood pressure;

* sitting systolic blood pressure (SBP) ≥ 140 mmHg and \<180 mmHg
* sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \<110 mmHg

Exclusion Criteria

* Secondary hypertension except primary aldosteronism or hypertensive emergency
* Patients diagnosed diabetic nephropathy
* Patients with type 1 diabetes
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
* Serum potassium level \< 3.0 or ≥ 5.1 milliequivalent (mEq)/L
Minimum Eligible Age

20 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

Locations

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Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital

Yokohama, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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CS3150-A-J307

Identifier Type: -

Identifier Source: org_study_id