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

NCT ID: NCT03847350

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2017-03-23

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.

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.

Conditions

Essential Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A.Menarini Asia-Pacific Holdings Pte Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dae-Hyeok Kim

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 19815121 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19404314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21845001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11607802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21061833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25267802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25492835 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21088095 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40083595 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33722290 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31693535 (View on PubMed)

Other Identifiers

MAKR/15/Neb-Hyp/001

Identifier Type: -

Identifier Source: org_study_id