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Completed

NCT Number: NCT02885662

Study of CS-3150 in Patients With Primary Aldosteronism

To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, 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
  • Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
  • Patients satisfying following blood pressure;
  • sitting systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg
  • sitting diastolic blood pressure (DBP) ≥ 90 mmHg and <110 mmHg

Exclusion criteria

  • Secondary hypertension except primary aldosteronism or hypertensive emergency
  • Patients diagnosed diabetic nephropathy
  • Patients with type 1 diabetes
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
  • Serum potassium level < 3.0 or ≥ 5.1 milliequivalent (mEq)/L

Treatment and study plan

CS-3150

Drug

CS-3150 2.5 to 5.0 mg , orally.

Primary outcomes

  1. Change from baseline in sitting blood pressure

    Time frame: Baseline to end of Week 12

    Change from baseline in sitting systolic and diastolic blood pressure

Secondary outcomes

  1. Time course of sitting blood pressure

    Time frame: Baseline to end of Week 12

    Time course of sitting systolic and diastolic blood pressure

  2. Proportion of patients achieving sitting blood pressure goal

    Time frame: Baseline to end of Week 12

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 31, 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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