| Eligibility |
Inclusion Criteria:
1. Male or female Caucasian uncontrolled hypertensive patients (see definition in
criterion 3) =18 and <65 years of age, in monotherapy either with ACE-i or BBs since
at least 1 month, at Screening (Visit 1)
2. Patients are able to understand and have freely given written informed consent at
Screening
3. Patients with mean sitting Systolic Blood Pressure =140 mmHg and =179 mmHg and/or mean
sitting Diastolic Blood Pressure = 90 mmHg and =109 mmHg at Screening (Visit 1)
4. Patient who are able to comply with all study procedures and who are available for the
duration of the study
5. Ability to take oral medication and willing to adhere to the drug regimen
6. A female patient of childbearing potential is eligible to participate if she is not
pregnant, or not breastfeeding. A woman is considered fertile following menarche and
until becoming postmenopausal unless permanently sterile. Women of childbearing
potential must agree to 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 less than 1% per year) and also must
refrain from donating or storing eggs during this time. Highly effective contraception
methods can be: a Combined (estrogen- and progestogen-containing) hormonal
contraception associated with inhibition of ovulation (oral, intravaginal,
transdermal) b Progestogen-only hormonal contraception associated with inhibition of
ovulation (oral, injectable, implantable) c Intrauterine device (IUD) d Intrauterine
hormone-releasing system (IUS) e Bilateral tubal occlusion f Vasectomized partner
(provided that partner is the sole sexual partner of the trial participant and that
the vasectomized partner has received medical assessment of the surgical success)
7. A male patient with female partner 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. Known contraindications, allergies, or hypersensitivities to any of the study
medications or excipient as outlined in the investigators brochures (IBs), summary of
product characteristics (SmPCs) or local package inserts for NEB and ZOF
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 within the last 6 months:
myocardial infarction, unstable angina pectoris, percutaneous coronary intervention,
bypass surgery, heart failure, hypertensive encephalopathy, cerebrovascular accident
(stroke), or transient ischemic attack
4. Patients with secondary hypertension of any etiology such as renal diseases,
pheochromocytoma, or Cushing's syndrome
5. Patients with severe heart failure (New York Heart Association classification III-IV),
a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow
(obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease
6. Patients with clinical evidence of renal disease as per the Investigator's judgement
(including renovascular occlusive disease, nephrectomy and/or renal transplant,
bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary
kidney, or severe renal impairment)
7. History of angioneurotic edema
8. Patients with clinically relevant hepatic impairment
9. Patients with sick sinus syndrome, including sino-atrial block
10. Patients with second- or third-degree heart block (without a pacemaker)
11. History of bronchospasm and bronchial asthma
12. Patients with bradycardia (heart rate <60 bpm)
13. Patient with metabolic acidosis
14. Patients with severe peripheral circulatory disturbances
15. Participation in another study within the last 4 weeks
16. Patients with diseases that, in the opinion of the Investigator, prevent a careful
adherence to the protocol
17. Pregnant and breastfeeding women. A pregnancy test will be performed on all women of
childbearing potential at each study visit
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