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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Change of glucose (HbA1c, fasting blood sugar), Na, K, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol |
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Inclusion Criteria:
Male and female patient aged 19 and older
In patient diagnosed with essential hypertension,
Subjects who have signed the written informed consent form for their voluntary participation
Exclusion Criteria:
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Male and female patient aged 19 and older
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Male and female patients with essential hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Dae-Hyeok Kim | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | 22332 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19815121 | Background | 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. | |
| 19404314 | Background | 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. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| 24 weeks |
| 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. | 24 weeks |
| 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 | 24 weeks |
| 21845001 | Background | 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. |
| 11607802 | Background | 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. |
| 21061833 | Background | 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. |
| 25267802 | Background | 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. |
| 25492835 | Background | 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. |
| 21088095 | Background | 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. |
| 40083595 | Derived | 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. |
| 33722290 | Derived | 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. |
| 31693535 | Derived | 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. |