Clinical trial NCT03847350: Observational Study of Efficacy and Safety of Nebivolol in Korean Patients With Essential Hypertension
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Lead sponsor: A.Menarini Asia-Pacific Holdings Pte Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 3250
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with essential hypertension

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.

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

Primary outcomes:
measure: Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: 24 weeks
Secondary outcomes:
measure: Controlled patient rate in targeted Systolic Blood Pressure and Diastolic Blood Pressure range
timeFrame: 24 weeks
measure: Change of glucose (HbA1c, fasting blood sugar), Na, K, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
timeFrame: 24 weeks
measure: Changes in Heart Rate and Heart Rate Variability after treatment with NEBILET® (Nebivolol) versus baseline values in patients receiving the concomitant antihypertensive therapies.
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Dae-Hyeok Kim
role: PRINCIPAL_INVESTIGATOR
References:
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