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Completed

NCT Number: NCT02345044

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

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.

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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 2

Primary location

Osaka, 530-0001, Japan

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 (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

Treatment and study plan

CS-3150

Drug

Placebo

Drug

Eplerenone

Drug

Primary outcomes

  1. Change from baseline in sitting systolic and diastolic blood pressure

    Time frame: baseline to end week 12

Secondary outcomes

  1. Change from baseline in 24-hr blood pressure (ABPM)

    Time frame: Baseline to end week 12

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Oct 8, 2019

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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