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

• Status: Completed
• Trial end date: 2017-07-08
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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.