Study of CS-3150 in Patients With Severe Hypertension

Severe Hypertension Clinical Trial

Official title:

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808026
• Other study ID #: CS3150-A-J304
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Severe Hypertension

Intervention

Drug:
• CS-3150
CS-3150 2.5 to 5mg, orally, once daily after breakfast

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		Baseline to end of Week 8
Secondary	Time course of systolic and diastolic blood pressure		Baseline to end of Week 8
Secondary	Proportion of patients achieving blood pressure control		Baseline to end of Week 8