Status:
COMPLETED
Observational Study of Efficacy and Safety of Nebivolol in Korean Patients With Essential Hypertension
Lead Sponsor:
A.Menarini Asia-Pacific Holdings Pte Ltd
Conditions:
Essential Hypertension
Eligibility:
All Genders
19+ years
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 profi...
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 v...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 23 2017
Estimated Enrollment :
3250 Patients enrolled
Trial Details
Trial ID
NCT03847350
Start Date
July 1 2015
End Date
March 23 2017
Last Update
February 20 2019
Active Locations (1)
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1
Inha University Hospital
Incheon, South Korea, 22332