Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
- Registration Number
- NCT02722265
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CS-3150 CS-3150 CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks
- Primary Outcome Measures
Name Time Method change from baseline in sitting systolic and diastolic blood pressure week 0 (baseline) to end of weeks 12, 28, and 52
- Secondary Outcome Measures
Name Time Method Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM) week 0 (baseline) to end of weeks 12, 28, and 52