Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension

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

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-08

Brief Summary

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To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.

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Detailed Description

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Conditions

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Essential 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 2.5mg to 5mg, orally, once daily for 28 or 52 weeks

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks

Interventions

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CS-3150

CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and \< 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)

Exclusion Criteria

* 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 ACE inhibitor, or ARB)
* Reversed day-night life cycle including overnight workers
* estimated glomerular filtration rate eGFR \< 60 mL/min/1.73 m\^2.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No