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Completed

NCT Number: NCT02808026

Study of CS-3150 in Patients With Severe Hypertension

To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

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Key information

Conditions

Severe Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sapporo, 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 to 80 years at informed consent
  • Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)

Exclusion criteria

  • Patients who are suspected hypertensive emergency
  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
  • eGFR < 60 mL/min/1.73 m^2.

Treatment and study plan

CS-3150

Drug

CS-3150 2.5 to 5mg, orally, once daily after breakfast

Primary outcomes

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

    Time frame: Baseline to end of Week 8

Secondary outcomes

  1. Time course of systolic and diastolic blood pressure

    Time frame: Baseline to end of Week 8

  2. Proportion of patients achieving blood pressure control

    Time frame: Baseline to end of Week 8

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)

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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