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Completed

NCT Number: NCT02807987

Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.

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Key information

Conditions

Hypertension With Moderate Renal Impairment Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagano, 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 or order to 80 or younger years at informed consent
  • Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg
  • Treatment with an ARB or ACE inhibitor
  • eGFR ≥ 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2

Exclusion criteria

  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Subjects under Insulin treatment
  • Subjects under or pre-planned for hemodialysis
  • Serum potassium level < 3.5 or ≥ 4.8 mEq/L

Treatment and study plan

CS-3150

Drug

CS-3150 1.25 to 2.5, 5mg, orally

Primary outcomes

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

    Time frame: Baseline to end of Week 12

    Time course of systolic and diastolic blood pressure

  2. Proportion of patients achieving blood pressure control

    Time frame: Baseline to end of Week 12

    Proportion of patients achieving blood pressure control

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 Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 21, 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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