| Eligibility |
Inclusion Criteria:
1. Male or female patients with Grade 1 - 2 hypertension with mean sitting SBP =140 mmHg
and =179 mmHg and/or mean sitting DBP =90 mmHg and =109 mmHg at screening (in
accordance with the 2018 European Society of Cardiology / European Society of
Hypertension guidelines definition), =18 and <65 years of age, on monotherapy
treatment either with BBs or CCBs for at least 4 weeks before Visit 1 (screening).
2. Patients are able to understand and have freely given written informed consent at
Screening Visit.
3. Patients who are able to comply with all study procedures and who are available for
the duration of the study.
4. Ability to take oral medication and willing to adhere to the drug regimen.
5. Female patients are eligible to participate if not pregnant, or not breastfeeding and
if they refrain from donating or storing eggs. For females of reproductive potential:
use of highly effective contraception (eg. method of birth control throughout the
study period and for 4 weeks after study completion defined as a method which results
in a failure rate of <1% per year) such as:
- Combined hormonal contraception (estrogen- and progestogen-containing) associated
with inhibition of ovulation (oral, intravaginal, and transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, and implantable).
- Intrauterine device.
- Intrauterine hormone-releasing system.
- Bilateral tubal occlusion.
- Vasectomized partner (procedure conducted at least 2 months before the
screening), (provided the partner is the sole sexual partner of the trial
participant and that the vasectomized partner has received medical assessment of
the surgical success).
6. A male patient must agree to use contraception during the whole study period and for
at least 1 week after the last dose of study treatment and refrain from donating
sperms during this period.
Exclusion Criteria:
1. Patients with significant history of hypersensitivity to nebivolol, amlodipine, other
BBs or other dihydropyridines, or any related products (including excipients of the
formulations) as outlined in the relevant Investigators Brochures, summary of product
characteristics12,13 or local package inserts for NEB and AML.
2. Patients with serious disorders (in the opinion of the Investigator) which may limit
the ability to evaluate the efficacy or safety of the tested medications, including
cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal,
endocrine or metabolic, hematological, or oncological, neurological, and psychiatric
diseases. The same applies for immunocompromised and/or neutropenic patients.
3. Patients having a history of the following conditions within the last 6 months:
myocardial infarction, unstable angina pectoris, percutaneous coronary intervention,
bypass surgery, heart failure, hypertensive encephalopathy, valve replacement
(transcatheter aortic valve implantation, mitraclip), cerebrovascular accident
(stroke), or transient ischemic attack.
4. Patients with condition of hypotension with SBP <90 mmHg and/or DBP <60 mmHg.
5. Acute heart failure, cardiogenic shock, or episodes of heart failure decompensation
requiring intravenous inotropic therapy.
6. Patients with secondary hypertension of any etiology including renal diseases,
pheochromocytoma, Cushing's syndrome, hyperaldosteronism, renovascular disease, and
thyroid disorders.
7. Patients with a narrowing of the aortic or bicuspid valve, an obstruction of cardiac
outflow (obstructive, hypertrophic cardiomyopathy), obstruction of the outflow tract
of the left ventricle (eg. high grade aortic stenosis) or symptomatic coronary
disease.
8. Patients with severe renal impairment or renal transplant.
9. Patients with clinically relevant hepatic impairment.
10. Patients with sick sinus syndrome, including sino-atrial block.
11. Patients with second- or third-degree heart block (without a pacemaker).
12. Patients with history of bronchospasm and bronchial asthma.
13. Patients with untreated pheochromocytoma.
14. Patients with bradycardia (heart rate <60 bpm; <50 bpm in patients already on BBs
treatment).
15. Patient with metabolic acidosis.
16. Patients with severe peripheral circulatory disturbances.
17. Participation in another interventional study within the last 4 weeks before Screening
Visit (Visit 1).
18. Patients with diseases that, in the opinion of the Investigator, prevent a careful
adherence to the protocol.
19. Patients using and not suitable for withdrawing the prohibited medications prior to
the administration of study treatment.
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