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

Hypertension Clinical Trial

Official title: Open-label, Multicenter, multinAtionaL, inteRventional Clinical Trial to Assess Efficacy and Safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients - ARTEMISIA Study

Status Recruiting

Clinical Trial Summary

Open-label, inteRventional clinical Trial to assess EffIcacy and safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients.

Clinical Trial Description

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 NEB and RAM in reducing SBP and DBP in hypertensive patients uncontrolled by monotherapy.

The trial will be conducted in approximately 20 investigational clinical sites in Bulgaria, Poland, and Hungary.

Note: For the purpose of this study, uncontrolled BP is defined as sitting SBP/DBP ≥130/80 mmHg.

Screening Visit 1 (Week -4):

Hypertensive patients with SBP ranging from ≥140 to ≤179 mmHg and DBP ranging from ≥90 to ≤109 mmHg on treatment, for at least 30 days prior to screening, with NEB 5 mg or any other BB, or RAM 5 mg or any other ACE-i will be screened for eligibility (Visit 1). Patients that did not meet eligibility criteria will be considered as screening failures and will not be re-screened.

After 4 weeks ±2 days in the Assessment period (Week 4), patients BP will be further evaluated at Visit 3:

patients with controlled BP levels (sitting SBP/DBP <130/80 mmHg) will continue the same extemporaneous combination, while patients with uncontrolled BP levels will be up-titrated from NEB/RAM 5/2.5 mg to NEB/RAM 5/5 mg for further 4 weeks ± 2 days.

After further 4 weeks ± 2 days (Week 8) the BP will be assessed again (Visit 4):

controlled patients will continue the same extemporaneous combination, while uncontrolled patients:

• if on NEB/RAM 5/2.5 mg, will be up-titrated to NEB/RAM 5/5 mg for further 4 weeks ± 2 days (Visit 5, Week 12);

• if on NEB/RAM 5/5 mg, will be up-titrated to NEB/RAM 5/10 mg for further 4 weeks ± 2 days (Visit 5, Week 12).

At the end of the Assessment period (12 weeks ± 2 days), at Visit 5:

antihypertensive effect of the extemporaneous combination (NEB/RAM 5/2.5 mg, NEB/RAM 5/5 mg or NEB/RAM 5/10 mg) will be evaluated.

To correctly evaluate the additional effect of the combination therapy, the number of patients with uncontrolled BP on NEB or RAM monotherapy needs to be balanced at Visit 2. To maintain a 1:1 ratio during the Assessment period, a cap of 110 patients for each treatment arm (i.e., NEB and RAM) will be included at Visit 2 to maintain a balanced number of uncontrolled patients entering the Assessment period for each drug.

The evaluation will be done every 50 patients. If the entrance in the Assessment period for 1 of the 2 tested drugs will deviate more than 5%, a corrective measure will be initiated: according to the enrollment site statistics, 1 or more sites will be informed to enroll a greater number of patients being treated with the least represented drug in the Assessment period. ;

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT06104423
• Study type: Interventional
• Source: Menarini International Operations Luxembourg SA
• Contact: Menarini International Operations Luxembourg SA
• Phone: 22649761
• Email: aconte@menarini.lu
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2, 2023
• Completion date: May 3, 2024