Study of CS-3150 in Patients With Severe Hypertension

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Mineralocorticoid Receptor Antagonists

Criteria

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.