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

Essential Hypertension Clinical Trial

Official title:

Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722265
• Other study ID #: CS3150-A-J302
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: July 8, 2017

Study information

• Verified date: October 2019
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: July 8, 2017
• Est. primary completion date: July 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in sitting systolic and diastolic blood pressure		week 0 (baseline) to end of weeks 12, 28, and 52
Secondary	Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)		week 0 (baseline) to end of weeks 12, 28, and 52