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

Daiichi Sankyo Co., Ltd.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Hypertension

Interventions

CS-3150DRUG

CS-3150 2.5mg, oral

olmesartan medoxomilDRUG

olmesartan medoxomil 10 mg, oral

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 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.

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Change from baseline in 24 hr blood pressure

Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12

Time frame: baseline to end of Week 12

Secondary Outcomes

Change from baseline in morning, evening, and night blood pressure.

Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.

Time frame: baseline to week 12

Change from baseline in sitting blood pressure

Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.

Time frame: baseline to week 12

Time course of 24 hr blood pressure and sitting blood pressure

Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)

Time frame: week 12

Proportion of patients achieving 24 hr and sitting blood pressure control

Time frame: week 12

Data from ClinicalTrials.gov

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