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

Essential Hypertension Clinical Trial

— BENEFIT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847350
• Other study ID #: MAKR/15/Neb-Hyp/001
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: March 23, 2017

Study information

• Verified date: January 2019
• Source: A.Menarini Asia-Pacific Holdings Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3250
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
A.Menarini Asia-Pacific Holdings Pte Ltd

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

Münzel 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. Review. — View Citation

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. — View Citation

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. Erratum in: J Hum Hypertens. 2010 Jun;24(6):430. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Ther Adv Cardiovasc Dis. 2011 Aug;5(4):213. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	24 weeks
Secondary	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
Secondary	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