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Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension

NCT ID: NCT02848170

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-04-30

Brief Summary

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Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.

Detailed Description

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Conditions

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Essential Hypertension

Keywords

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essential hypertension mineralocorticoid receptor antagonist Developmental Phase III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 12 weeks

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 2.5mg, oral

olmesartan medoxomil

olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks

Group Type ACTIVE_COMPARATOR

olmesartan medoxomil

Intervention Type DRUG

olmesartan medoxomil 10 mg, oral

Interventions

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CS-3150

CS-3150 2.5mg, oral

Intervention Type DRUG

olmesartan medoxomil

olmesartan medoxomil 10 mg, oral

Intervention Type DRUG

Other Intervention Names

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Benicar

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \< 110 mmHg)

Exclusion Criteria

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 milliequivalent (mEq)/L
* 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

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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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CS3150-A-J303

Identifier Type: -

Identifier Source: org_study_id