Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Patients with Essential Hypertensio

Phase 2

Completed

• Conditions: Essential hypertension

• Registration Number: JPRN-jRCT2080221876
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

In the CS-3150 group, the mean change from baseline and end-of-treatment blood pressure values in sitting blood pressure and 24-hour blood pressure were greater with increasing dose, and the pharmacodynamic endpoints in the blood were roughly greater with increasing dose. Regarding safety, there were no serious adverse events, severe adverse events, or adverse events leading to study discontinuation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-07
• Study Completion: 2013-05-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Main Inclusion Criteria;
- Sitting blood pressure:stable, mean systolic BP>=140 and <180 mmHg, and mean diastolic BP>=90 and <110 mmHg.
- 24-hour mean BP by ambulatory blood pressure monitoring (ABPM) : systolic BP >- 130 mmHg, and diastolic BP >-80 mm Hg.

Exclusion Criteria

1) Secondary hypertension or malignant hypertension
2) Subjects with diabetes or with treatment for diabetes
3) Serum potassium level < 3.5 or >= 5.1 mEq/L
4) Reversed day-night life cycle including overnight workers
5) eGFR < 60 mL/min/1.73 m^2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Change from baseline in sitting systolic and diastolic blood pressure<br>Adverse events

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Change from baseline in 24-hr blood pressure (ABPM)