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

An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02848170

Enrollment

Registered

2016-07-28

Start date

2016-08-31

Completion date

2017-04-30

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

essential hypertension, mineralocorticoid receptor antagonist, Developmental Phase III

Brief summary

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

Interventions

DRUGCS-3150

CS-3150 2.5mg, oral

DRUGolmesartan medoxomil

olmesartan medoxomil 10 mg, oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in 24 hr blood pressure	baseline to end of Week 12	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

Secondary

Measure	Time frame	Description
Change from baseline in morning, evening, and night blood pressure.	baseline to week 12	Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Change from baseline in sitting blood pressure	baseline to week 12	Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Time course of 24 hr blood pressure and sitting blood pressure	week 12	Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)
Proportion of patients achieving 24 hr and sitting blood pressure control	week 12	Proportion of patients achieving 24 hr and sitting blood pressure control

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026