A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

Daiichi Sankyo426 enrolled

Overview

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

426

Conditions

Essential Hypertension

Interventions

CS-3150DRUG

placeboDRUG

eplerenoneDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects aged 20 years or older at informed consent * Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and \< 180 mmHg, Sitting DBP ≥ 90 mmHg and \< 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP) Exclusion Criteria: * Secondary hypertension or malignant hypertension * Diabetes mellitus with albuminuria * Serum potassium level \< 3.5 or ≥ 5.1 mEq/L * Reversed day-night life cycle including overnight workers * eGFR \< 60 mL/min/1.73 m\^2

Locations (1)

Unnamed facility

Osaka, Japan

Outcomes

Primary Outcomes

Change from baseline in sitting systolic and diastolic blood pressure

Time frame: baseline to end week 12

Secondary Outcomes

Change from baseline in 24-hr blood pressure (ABPM)

Time frame: Baseline to end week 12

Data from ClinicalTrials.gov

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