Study of CS-3150 in Patients With Severe Hypertension

Phase 3

Completed

• Conditions: Severe Hypertension
• Interventions: Drug: CS-3150

• Registration Number: NCT02808026
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-21
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS-3150	CS-3150	CS-3150 2.5 to 5mg, orally, once daily after breakfast for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting systolic and diastolic blood pressure	Baseline to end of Week 8

Secondary Outcome Measures

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