A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

Essential Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345044
• Other study ID #: CS3150-A-J203
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: October 2015

Study information

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

Clinical Trial Summary

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• 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 (Sitting SBP = 140 mmHg and < 180 mmHg, Sitting DBP = 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• Diabetes mellitus with albuminuria

• Serum potassium level < 3.5 or = 5.1 mEq/L

• Reversed day-night life cycle including overnight workers

• eGFR < 60 mL/min/1.73 m^2

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• CS-3150

• placebo

• eplerenone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

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 week 12
Secondary	Change from baseline in 24-hr blood pressure (ABPM)		Baseline to end week 12