Study of CS-3150 in Patients With Severe Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Severe Hypertension

Treatments: Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02808026

CS3150-A-J304

Details and patient eligibility

About

To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

Enrollment: 20 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged 20 to 80 years at informed consent
• Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)

Exclusion criteria

• Patients who are suspected hypertensive emergency
• 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 RA inhibitor)
• 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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20 participants in 1 patient group

CS-3150

Experimental group

Description:

CS-3150 2.5 to 5mg, orally, once daily after breakfast for 8 weeks

Treatment:

Drug: CS-3150