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Study of CS-3150 in Patients With Severe Hypertension

NCT ID: NCT02808026

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-02-28

Brief Summary

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To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

Detailed Description

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Conditions

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Severe Hypertension

Keywords

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severe hypertension grade III hypertension mineralocorticoid receptor antagonist

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 5mg, orally, once daily after breakfast for 8 weeks

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 2.5 to 5mg, orally, once daily after breakfast

Interventions

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CS-3150

CS-3150 2.5 to 5mg, orally, once daily after breakfast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects aged 20 to 80 years at informed consent
* Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)

Exclusion Criteria

* Patients who are suspected hypertensive emergency
* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
* eGFR \< 60 mL/min/1.73 m\^2.
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

Locations

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Sapporo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CS3150-A-J304

Identifier Type: -

Identifier Source: org_study_id