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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02722265

CS3150-A-J302

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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368 participants in 1 patient group

CS-3150

Experimental group

Description:

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

Treatment:

Drug: CS-3150