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Completed

NCT Number: NCT02890173

Study of CS-3150 in Patients With Essential Hypertension

To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sapporo, Hokkaido, Japan

About this study

Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.

Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects aged 20 years or older at informed consent
  • Subjects with essential hypertension satisfying the following blood pressure criteria;
  • Sitting SBP: ≥ 140 mmHg and < 180 mmHg
  • Sitting DBP: ≥ 90 mmHg and < 110 mmHg
  • Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion criteria

  • Secondary hypertension or malignant hypertension
  • Diabetic nephropathy or 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

Treatment and study plan

CS-3150

Drug

Eplerenone

Drug

Other names: Inspra

Primary outcomes

  1. Change from baseline in sitting blood pressure

    Time frame: Baseline to end of Week 12

    Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).

Secondary outcomes

  1. Change from baseline in 24 hour average blood pressure

    Time frame: Baseline to end of Week 12

    Change from baseline in 24 hour average systolic and diastolic blood pressure.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)

Acronym: ESAX-HTN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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