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

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ClinicalTrials.gov Identifier: NCT03847350
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
A.Menarini Asia-Pacific Holdings Pte Ltd

Brief Summary:

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.


Condition or disease
Essential Hypertension

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 3250 participants
Observational Model: Other
Time Perspective: Prospective
Official 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.
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male and female patient aged 19 and older
Sampling Method:   Probability Sample
Study Population
Male and female patients with essential hypertension
Criteria

Inclusion Criteria:

  1. Male and female patient aged 19 and older
  2. 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.)
  3. Subjects who have signed the written informed consent form for their voluntary participation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847350


Locations
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Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of, 22332
Sponsors and Collaborators
A.Menarini Asia-Pacific Holdings Pte Ltd
Investigators
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Principal Investigator: Dae-Hyeok Kim Inha University Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A.Menarini Asia-Pacific Holdings Pte Ltd
ClinicalTrials.gov Identifier: NCT03847350    
Other Study ID Numbers: MAKR/15/Neb-Hyp/001
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases