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Completed

NCT Number: NCT03847350

Observational Study of Efficacy and Safety of Nebivolol in Korean Patients With Essential Hypertension

The purpose of this study is:

To evaluate the effects of NEBILET®(Nebivolol), used as monotherapy or in combination with other antihypertensive agents, in the control of BP and in the metabolic profile of patients with essential hypertension (with or without co-morbidities) after 12 weeks and 24 weeks.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inha University Hospital

Incheon, 22332, South Korea

About this study

Nebivolol, the third-generation beta-blocker with vasodilatory effect, potentiates nitric oxide by activating the synthesis of nitric oxide of vascular endothelial cells and improves the function of vascular endothelial cells by reducing oxidation stress. The efficacy of NEBILET®(Nebivolol) has been demonstrated in randomized controlled trials not only as monotherapy but also as add-on therapy with angiotensin-converting-enzyme inhibitor, angiotensin II receptor blocker, diuretic and other anti-hypertensive agents in lowering the blood pressure.

Based on previous study results mentioned above, the present study aims to observe the effect of NEBILET®(Nebivolol) on controlling blood pressure and metabolic profile change in Korean patients with hypertension under routine clinical practice.

In addition, this study aims to identify additional benefits of NEBILET®(Nebivolol) administration in patients with essential hypertension under various treatment environments and existing co-morbidities in Korea, expected to provide detailed information about efficacy of blood pressure control, lipid and carbohydrate metabolism of NEBILET®(Nebivolol) administration in Korean patients with essential hypertension.

Who can participate

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

Inclusion criteria

  • Male and female patient aged 19 and older
  • In patient diagnosed with essential hypertension,
  • Patients who can be first treated with NEBILET®(Nebivolol) to lower high blood pressure
  • In patients who are receiving other antihypertensive medications, those who can switch one of the antihypertensive agents to NEBILET®(Nebivolol) or use NEBILET®(Nebivolol) as an additional therapy (In case where one of other antihypertensive agents is switched to NEBILET®(Nebivolol), it is imperative that the dose of the previous medication should exhibit the same antihypertensive effect as NEBILET®(Nebivolol) 5 mg.)
  • Subjects who have signed the written informed consent form for their voluntary participation

Exclusion criteria

  • Patient with hypersensitivity to the NEBILET®(Nebivolol) substance
  • Patient with history of bronchospasm
  • Patient with history of bronchial asthma
  • Patient with metabolic acidosis
  • Patient with bradycardia(heart rate< 60 bpm)
  • Patient with second and third degree atrioventricular block
  • Patient with acute heart failure, cardiogenic shock, or episodes of heart failure decompensation requiring i.v. inotropic therapy)
  • Patient with uncontrolled severe heart failure
  • Patient with hypotension (Systolic Blood Pressure < 90mmHg)
  • Patient with severe peripheral circulatory disturbances
  • Patient with sick sinus syndrome including sino-atrial block
  • Patient with untreated pheochromocytoma
  • Patient with hepatic insufficiency
  • Patient with impaired liver function
  • Pregnant woman
  • Nursing mother
  • Patient with chronic heart failure who has severe renal insufficiency (serum creatinine ≥ 250 micro mol/L)
  • Patient with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption
  • Patient who has participated in other clinical trial within the last 3 months

Treatment and study plan

Primary outcomes

  1. Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure

    Time frame: 24 weeks

    Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure after 12 weeks(±2 weeks) and 24 weeks (±2 weeks) compared to Baseline

Secondary outcomes

  1. Controlled patient rate in targeted Systolic Blood Pressure and Diastolic Blood Pressure range

    Time frame: 24 weeks

    Controlled patient rate in targeted Systolic Blood Pressure and Diastolic Blood Pressure range after 12 weeks (±2 weeks) and 24 weeks (±2 weeks) compared to Baseline

  2. Change of glucose (HbA1c, fasting blood sugar), Na, K, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol

    Time frame: 24 weeks

    Change of glucose (HbA1c, fasting blood sugar), Na, K, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol at 12 weeks (±2 weeks) and 24 weeks (±2 weeks) compared to Baseline

  3. Changes in Heart Rate and Heart Rate Variability after treatment with NEBILET® (Nebivolol) versus baseline values in patients receiving the concomitant antihypertensive therapies.

    Time frame: 24 weeks

    Changes in Heart Rate and Heart Rate Variability at 12 weeks (±2 weeks) and 24 weeks (±2 weeks) after treatment with NEBILET® (Nebivolol) versus baseline values in patients receiving the concomitant antihypertensive therapies.

  4. Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure compared to baseline depending on the treatment status and type of anti-hypertensive concomitant medication

    Time frame: 24 weeks

    Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure after 12 weeks and 24 weeks compared to baseline depending on the treatment status and type of anti-hypertensive concomitant medication

Sponsors and collaborators

Lead sponsor

A.Menarini Asia-Pacific Holdings Pte Ltd

Industry

Registry information

Official study title

An Observational Study to Identify BEnefits After 24 Weeks of NEBILET®(Nebivolol) Administration For Essential hypertensIon Patients With Various Co-morbidities and Treatment Environments in KOREA.

Acronym: BENEFIT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2019
Registry last updated
Feb 20, 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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