Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05513937
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2022-08-22
Brief Title:
Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy
Sponsor:
Menarini International Operations Luxembourg SA
Organization:
Menarini International Operations Luxembourg SA
Study Overview
Official Title:
Open-laBel Multicenter multinatiOnal inTerventional Clinical Trial to Assess effIcacy and Safety of the Extemporaneous Combination of nEbivoLol and amLodipine in Grade 1-2 Hypertensive patIents Versus Each Monotherapy
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Botticelli
Brief 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
Detailed 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 mgdaily 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 11 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 SBPDBP 13080 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 SBPDBP 13080 mmHg andor 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 SBPDBP 13080 mmHg will continue the same extemporaneous combination while patients with uncontrolled BP levels will be uptitrated from extemporaneous combination NEBAML 55 mg to extemporaneous combination of NEBAML 510 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 11 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
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 mgdaily 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 11 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 SBPDBP 13080 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 SBPDBP 13080 mmHg andor 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 SBPDBP 13080 mmHg will continue the same extemporaneous combination while patients with uncontrolled BP levels will be uptitrated from extemporaneous combination NEBAML 55 mg to extemporaneous combination of NEBAML 510 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None