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

Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02722265

Enrollment

368

Registered

2016-03-29

Start date

2016-03-31

Completion date

2017-07-08

Last updated

2019-10-08

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, Long-term treatment, Mineralocorticoid receptor antagonist

Brief summary

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.

Interventions

DRUGCS-3150

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

Study design

Allocation

Intervention model

SINGLE_GROUP

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, 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.

Design outcomes

Primary

Measure	Time frame
change from baseline in sitting systolic and diastolic blood pressure	week 0 (baseline) to end of weeks 12, 28, and 52

Secondary

Measure	Time frame
Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)	week 0 (baseline) to end of weeks 12, 28, and 52

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026