Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy (Botticelli)

  • STATUS
    Recruiting
  • participants needed
    290
  • sponsor
    Menarini International Operations Luxembourg SA
Updated on 30 January 2023
hypertension
amlodipine
amlodipine 5 mg
nebivolol

Summary

Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Nebivolol 5 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment inpatients with uncontrolled BP previously treated with Nebivolol (NEB) or Amlodipine (5 mg) monotherapies for at least 4 weeks.

Description

Approximately 290 patients are planned to be screened to ensure at least 216 patients complete the run-in period and start with the assessment period.

Grade 1 - 2 hypertensive patients [BP ranging from ≥140 to ≤179 mmHg for Systolic Blood Pressure (SBP) and from ≥90 to ≤109 mmHg for Diastolic Blood Pressure (DBP)] on treatment with any Beta Blocker (BB) or Calcium Channel Blocker (CCB), including NEB (only 5 mg dosage allowed) or AML (only 5 mg dosage allowed) for at least one month prior to Visit 1 will be screened for eligibility.

Allowed CCBs at screening includes Felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, and nisoldipine. Patients treated with Amlodipine or Nebivolol in dosages higher than 5 mg/daily will not be eligible.

On the same day of the Screening visit, the eligible patients will enter into a run-in period of 4 weeks after screening, during which:

  • Patients receiving NEB 5 mg or AML 5 mg will continue the same therapy for 4 weeks.
  • Patients on any other BBs or CCBs will be switched to NEB 5 mg or AML 5 mg. Patients entering this phase in therapy with NEB 5 mg or AML 5 mg should be in a 1:1 ratio.

After 4 weeks (±2 days) of run-in period of monotherapy, the BP will be further assessed (Visit 2). Patients with uncontrolled BP levels (sitting SBP/DBP ≥130/80 mmHg) at Visit 2, with the 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 5 mg and AML 5 mg. Patients with controlled BP levels (sitting SBP/DBP <130/80 mmHg) and/or who do not tolerate the treatment or have an adherence range below 80% or above 120%, will be withdrawn from the study.

After 4 weeks ±2 days in the assessment period, 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 uptitrated from extemporaneous combination NEB/AML 5/5 mg to extemporaneous combination of NEB/AML 5/10 mg for further 4 weeks.

At the end of the assessment period (8 weeks ±4 days), the patients will attend an End of Treatment Visit 4.

To correctly evaluate the additional effect of the combination therapy, the number of patients with uncontrolled BP on NEB or AML monotherapy needs to be balanced at Visit 2. In order to maintain a 1:1 ratio during the assessment period, a cap of 110 patients for each treatment arm (ie. NEB and AML) will be included at Visit 2 in order 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 rate of entrance in the assessment period for one of the 2 tested drugs will deviate more than 5%, a corrective measure will be initiated.

Details
Condition Hypertension
Treatment Amlodipine, Nebivolol
Clinical Study IdentifierNCT05513937
SponsorMenarini International Operations Luxembourg SA
Last Modified on30 January 2023

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