Open-label inteRventional Clinical Trial to Assess Efficacy and Safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients

This is a Phase IV, interventional, multicenter, open-label, multinational study with 2 study periods (a Run-in period of 4 weeks and an Assessment period of 12 weeks) to assess the efficacy and safety of the extemporaneous combination of Nebivolol (NEB) and Ramipril (RAM) in reducing Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) in hypertensive patients uncontrolled by monotherapy.

The trial was conducted in 16 investigational clinical sites in Bulgaria, Poland, and Hungary.

Note: For the purpose of this study, uncontrolled blood pressure (BP) is defined as sitting SBP/DBP:

* ≥ 130/80 mmHg in patients \< 65 years old * ≥ 140/80 mmHg in patients ≥ 65 years old

Screening Visit 1 (Week -4):

Hypertensive patients with SBP ranging from ≥ 140 to ≤ 179 mmHg and/or DBP ranging from ≥ 90 to ≤ 109 mmHg on treatment, for at least 30 days prior to screening, with NEB 5 mg or any other Beta Blockers (BBs), or RAM 5 mg or any other Angiotensin-converting enzyme inhibitors (ACE-i) will be screened for eligibility (Visit1). Patients that did not meet eligibility criteria will be considered as screening failures and will not be re-screened.

Run-in period from Visit 1 (Week -4) to Visit 2 (Week 0):

On the same day of the Screening Visit, eligible patients will enter a Run-in period, during which:

* Patients receiving NEB 5 mg or RAM 5 mg will continue the same therapy for 4 weeks. * Patients on any other BB will be assigned to monotherapy with NEB 5 mg while patients on any other ACE-i will be assigned to monotherapy with RAM 5 mg for 4 weeks. The study is designed in order to ensure that 1:1 ratio between patients in the NEB and RAM arms will be achieved.

Assessment period from Visit 2 (Week 0) to Visit 5 (Week 12):

After 4 weeks (± 2 days) of the Run-in period of monotherapy (Week 0), BP will be further assessed at Visit 2. Patients with uncontrolled BP levels (sitting BP ≥ 130/80 mmHg in patients \< 65 years old/sitting BP ≥ 140/80 mmHg in patients ≥ 65 years old) at Visit 2, with adequate treatment adherence (ranging between 80% to 120%) and who did tolerate the treatment, will enter into the Assessment period and will be assigned to the extemporaneous combination of NEB/RAM 5/2.5 mg. Patients with controlled BP levels (sitting BP \< 130/80 mmHg in patients \< 65 years old/sitting BP \< 140/80 mmHg in patients ≥ 65 years old) and/or who do not tolerate the treatment or have an adherence range below 80% or above 120%, will be withdrawn from the study (drop-out patients).