Cardiovascular Disease Hypertensive patients MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Sponsors
Menarini International Operations Luxembourg SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient will be considered eligible to be enrolled in the study only if he/she meets all the following inclusion criteria: 1. Willing to comply with all study activities and procedures for the duration of the study and provided signed, written informed consent prior to any study procedures at Screening Visit. 2. Male or female patients =18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any patient who meets any of the following criteria will not qualify for entry into the study: 1. Patients with documented history of hypersensitivity to NEB, RAM, other BBs or other ACE-is, or any related products (including excipients of the formulations) as outlined in the relevant Investigators Brochures, summary of product characteristics or local package inserts for Nebivolol and Ramipril. 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 (12 months before enrolment), cardiogenic shock, or episodes of heart failure decompensation requiring intravenous inotropic therapy. 6. Patients with secondary hypertension of any etiology including renal diseases, Cushing’s syndrome, hyperaldosteronism, renovascular disease and thyroid disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antihypertensive efficacy of the extemporaneous combination of NEB 5 mg with RAM 2.5/5/10 mg in lowering sitting diastolic blood pressure (DBP) between Visit 2 (Week 0) and Visit 5 (Week 12) in patients with uncontrolled blood pressure (BP)* previously treated with NEB 5 mg or RAM 5 mg monotherapies for at least 30 days. .For the purpose of this study, uncontrolled BP is defined as sitting SBP/DBP =130/80 mmHg.;Secondary Objective: • To assess the antihypertensive efficacy of the extemporaneous combination of NEB 5 mg with RAM 2.5/5/10 mg in lowering sitting systolic BP (SBP) between Visit 2 (Week 0) and Visit 5 (Week 12) in patients with uncontrolled BP * previously treated with NEB 5 mg or RAM 5 mg monotherapies for at least 30 days. • To assess the antihypertensive efficacy of the extemporaneous combination of NEB 5 mg with RAM 2.5/5/10 mg, in lowering sitting DBP and SBP between: - Visit 2 (Week 0) and Visit 3 (Week 4) - Visit 2 (Week 0) and Visit 4 (Week 8) • To assess the antihypertensive efficacy of the extemporaneous combination of NEB 5 mg with RAM 2.5/5/10 mg by evaluating the patients who achieved the standard BP goal (sitting BP <140/90 mmHg) at Visit 5 (Week 12). • To assess the antihypertensive efficacy of the extemporaneous combination of NEB 5 mg with RAM 2.5/5/10 mg by evaluating the patients who achieved the optimal BP goal (sitting BP <130/80 mmHg) at Visit 5 (Week 12). ;Primary end point(s): The primary endpoint is the change in mean sitting DBP between Visit 2 (Week 0) and Visit 5 (Week 12). The statistical hypothesis will be defined as below: H0: There is no change or increase in the sitting DBP post combination therapy . H1: There is a decrease in the sitting DBP post combination therapy. The above hypothesis will be tested as following: • Change from baseline in sitting DBP from prior and post combination therapy will be tested using paired t-test with one-sided significance level of 2.5%. The | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints • Change in mean sitting SBP between Visit 2 (Week 0) and Visit 5 (Week 12). • Change in mean sitting DBP and SBP between: o Visit 2 (Week 0) and Visit 3 (Week 4) o Visit 2 (Week 0) and Visit 4 (Week 8) • Number and proportion of patients achieving the standard BP goal (sitting BP<140/90 mmHg) at Visit 5 (Week 12). • Number and proportion of patients achieving the optimal BP goal (sitting BP<130/80 mmHg) at Visit 5 (Week 12). • Adherence to treatment as (% of doses taken/doses to be taken) at Visit 2 (Week 0), at Visit 3 (Week 4), at Visit 4 (Week 8) and at Visit 5 (Week 12). • Safety and tolerability of the monotherapies (NEB 5 mg and RAM 5 mg) and of the extemporaneous combination (NEB/RAM 5/2.5 mg, NEB/RAM 5/5 mg, NEB/RAM 5/10 mg) measured by incidence, intensity (severity), seriousness of adverse events during the study period, (Screening, Run-in period and Assessment period), relationship to the study treatments, clinically significant abnormal change in vital signs, electrocardiogram (ECG), laboratory parameters, and use of concomitant medications at Visit 2 (Week 0), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12).;Timepoint(s) of evaluation of this end point: measured in • Change in mean sitting SBP between Visit 2 (Week 0) and Visit 5 (Week 12). • Change in mean sitting DBP and SBP between: o Visit 2 (Week 0) and Visit 3 (Week 4) o Visit 2 (Week 0) and Visit 4 (Week 8) | — |
Countries
Bulgaria, Hungary
Contacts
Public ContactSimone Baldini, MD, Global Clin Man
A. MENARINI I.F.R SrL
Outcome results
None listed