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Essential HypertensionBENEFITNCT03847350

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

An observational study of Essential Hypertension, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Essential Hypertension
How many people
3,250 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2015to 23 Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

Study population: Male and female patients with essential hypertension

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inha University Hospital

    Incheon, 22332

Other trials in South Korea

About this study

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.

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.

Read the 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.

Medical subject headings
Essential Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 weeks

Secondary outcomes (4)

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

    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

    Measured: 24 weeks

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

    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

    Measured: 24 weeks

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

    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.

    Measured: 24 weeks

  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

    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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2019
  2. Study start1 Jul 2015
  3. Primary completion23 Mar 2017
  4. Study completion23 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03847350
Sponsor's protocol ID
MAKR/15/Neb-Hyp/001
Acronym
BENEFIT
Status last verified
Jan 2019
First submitted
15 Nov 2018
Last updated
20 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munzel T, Gori T. Nebivolol: the somewhat-different beta-adrenergic receptor blocker. J Am Coll Cardiol. 2009 Oct 13;54(16):1491-9. doi: 10.1016/j.jacc.2009.05.066.

    PubMed 19815121

  • Neutel JM, Smith DH, Gradman AH. Adding nebivolol to ongoing antihypertensive therapy improves blood pressure and response rates in patients with uncontrolled stage I-II hypertension. J Hum Hypertens. 2010 Jan;24(1):64-73. doi: 10.1038/jhh.2009.33.

    PubMed 19404314

  • Badar VA, Hiware SK, Shrivastava MP, Thawani VR, Hardas MM. Comparison of nebivolol and atenolol on blood pressure, blood sugar, and lipid profile in patients of essential hypertension. Indian J Pharmacol. 2011 Jul;43(4):437-40. doi: 10.4103/0253-7613.83117.

    PubMed 21845001

  • Predel HG, Mainka W, Schillings W, Knigge H, Montiel J, Fallois J, Agrawal R, Schramm T, Graf C, Giannetti BM, Bjarnason-Wehrens B, Prinz U, Rost RE. Integrated effects of the vasodilating beta-blocker nebivolol on exercise performance, energy metabolism, cardiovascular and neurohormonal parameters in physically active patients with arterial hypertension. J Hum Hypertens. 2001 Oct;15(10):715-21. doi: 10.1038/sj.jhh.1001257.

    PubMed 11607802

  • Van Bortel LM. Efficacy, tolerability and safety of nebivolol in patients with hypertension and diabetes: a post-marketing surveillance study. Eur Rev Med Pharmacol Sci. 2010 Sep;14(9):749-58.

    PubMed 21061833

  • Okamoto LE, Gamboa A, Shibao CA, Arnold AC, Choi L, Black BK, Raj SR, Robertson D, Biaggioni I. Nebivolol, but not metoprolol, lowers blood pressure in nitric oxide-sensitive human hypertension. Hypertension. 2014 Dec;64(6):1241-7. doi: 10.1161/HYPERTENSIONAHA.114.04116. Epub 2014 Sep 29.

    PubMed 25267802

  • Neutel JM, Giles TD, Punzi H, Weiss RJ, Li H, Finck A. Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study. J Am Soc Hypertens. 2014 Dec;8(12):915-20. doi: 10.1016/j.jash.2014.09.017. Epub 2014 Sep 28.

    PubMed 25492835

  • Punzi H, Lewin A, Lukic T, Goodin T, Wei Chen. Efficacy and safety of nebivolol in Hispanics with stage I-II hypertension: a randomized placebo-controlled trial. Ther Adv Cardiovasc Dis. 2010 Dec;4(6):349-57. doi: 10.1177/1753944710387629.

    PubMed 21088095

  • Shin J, Cha DH, Bae WH, Jung IH, Hong SP, Kim SH, Do JY, Hwang WM, Koh YY, Mancia G, Manolis AJ, Lee M. Posttreatment pulse rate reduction and not baseline pulse rate as an indicator of blood pressure response to nebivolol: a subanalysis from the real-world BENEFIT-KOREA study. Clin Hypertens. 2025 Mar 1;31:e8. doi: 10.5646/ch.2025.31.e8. eCollection 2025.

    PubMed 40083595

  • Cho KI, Jeon DW, Ahn HS, Jin DK, Lee HS, Lee JY, Lim HS, Manolis AJ, Rha SW, Park SW. Efficacy and safety of nebivolol in Korean patients with hypertension by age and sex: a subanalysis from the BENEFIT-KOREA study. Clin Hypertens. 2021 Mar 15;27(1):9. doi: 10.1186/s40885-021-00165-3.

    PubMed 33722290

  • Shin J, Choi YJ, Hong GR, Jeon DW, Kim DH, Koh YY, Mancia G, Manolis AJ, Yoon HJ, Park SW. Real-world efficacy and safety of nebivolol in Korean patients with hypertension from the BENEFIT KOREA study. J Hypertens. 2020 Mar;38(3):527-535. doi: 10.1097/HJH.0000000000002296.

    PubMed 31693535

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Hypertension, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03847350, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.

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