HypertensionPhase 4BotticelliNCT05513937
Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy
A Phase 4 study testing Nebivolol and Amlodipine in people with Hypertension, run by Menarini International Operations Luxembourg SA at 1 site in Bulgaria.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteBulgaria
- Study dates
- 12 May 2022to 15 Nov 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with Grade 1 - 2 hypertension with mean sitting SBP ≥140 mmHg and ≤179 mmHg and/or mean sitting DBP ≥90 mmHg and ≤109 mmHg at screening (in accordance with the 2018 European Society of Cardiology / European Society of Hypertension guidelines definition), ≥18 and <65 years of age, on monotherapy treatment either with BBs or CCBs for at least 4 weeks before Visit 1 (screening).
- Patients are able to understand and have freely given written informed consent at Screening Visit.
- Patients who are able to comply with all study procedures and who are available for the duration of the study.
- Ability to take oral medication and willing to adhere to the drug regimen.
- Female patients are eligible to participate if not pregnant, or not breastfeeding and if they refrain from donating or storing eggs. For females of reproductive potential: use of highly effective contraception (eg. method of birth control throughout the study period and for 4 weeks after study completion defined as a method which results in a failure rate of <1% per year) such as:
- Combined hormonal contraception (estrogen- and progestogen-containing) associated with inhibition of ovulation (oral, intravaginal, and transdermal).
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- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable).
- Intrauterine device.
- Intrauterine hormone-releasing system.
- Bilateral tubal occlusion.
- Vasectomized partner (procedure conducted at least 2 months before the screening), (provided the partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success).
- A male patient must agree to use contraception during the whole study period and for at least 1 week after the last dose of study treatment and refrain from donating sperms during this period.
Who cannot join
- Patients with significant history of hypersensitivity to nebivolol, amlodipine, other BBs or other dihydropyridines, or any related products (including excipients of the formulations) as outlined in the relevant Investigators Brochures, summary of product characteristics12,13 or local package inserts for NEB and AML.
- 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.
- 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.
- Patients with condition of hypotension with SBP <90 mmHg and/or DBP <60 mmHg.
- Acute heart failure, cardiogenic shock, or episodes of heart failure decompensation requiring intravenous inotropic therapy.
- Patients with secondary hypertension of any etiology including renal diseases, pheochromocytoma, Cushing's syndrome, hyperaldosteronism, renovascular disease, and thyroid disorders.
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- Patients with a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy), obstruction of the outflow tract of the left ventricle (eg. high grade aortic stenosis) or symptomatic coronary disease.
- Patients with severe renal impairment or renal transplant.
- Patients with clinically relevant hepatic impairment.
- Patients with sick sinus syndrome, including sino-atrial block.
- Patients with second- or third-degree heart block (without a pacemaker).
- Patients with history of bronchospasm and bronchial asthma.
- Patients with untreated pheochromocytoma.
- Patients with bradycardia (heart rate <60 bpm; <50 bpm in patients already on BBs treatment).
- Patient with metabolic acidosis.
- Patients with severe peripheral circulatory disturbances.
- Participation in another interventional study within the last 4 weeks before Screening Visit (Visit 1).
- Patients with diseases that, in the opinion of the Investigator, prevent a careful adherence to the protocol.
- Patients using and not suitable for withdrawing the prohibited medications prior to the administration of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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.
- Conditions
- Hypertension
- Being tested
- Nebivolol, Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Tablets administered orally once daily according instructions provided by Principal Investigator.
AmlodipineDrug
Tablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator.
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol 5 mg | Active comparator | MONOTHERAPY PHASE 4 weeks (Run-in from -4 week to week 0):
patients will be treated with Nebivolol 5mg
COMBINATION THERAPY PHASE 8 weeks (from week 0 to week 8):
uncontrolled patients during Monotherapy Phase will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4). Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Receives: Drug: Nebivolol; Drug: Amlodipine |
| Amlodipine 5/10 mg | Active comparator | MONOTHERAPY PHASE 4 weeks (Run-in from -4 week to week 0):
patients will be treated with Amlodipine 5mg
COMBINATION THERAPY PHASE 8 weeks (from week 0 to week 8):
uncontrolled patients during Monotherapy Phase will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4). Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Receives: Drug: Nebivolol; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8)
To assess the antihypertensive efficacy of the extemporaneous combination of Nebivolol (NEB) 5 mg in combination with Amlodipine (AML) 5 mg or AML 10 mg in lowering the sitting diastolic BP between Visit 2 (Week 0) and Visit 4 (Week 8) in patients with uncontrolled BP previously treated with Nebivolol or Amlodipine (5 mg) monotherapies for at least 4 weeks during run-in period.
Measured: From Visit 2 (week 0) to Visit 4 (week 8) for a total of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start12 May 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini International Operations Luxembourg SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Volpe, Principal investigator, University "Sapienza" Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513937
- Sponsor's protocol ID
- MEIN/21/AmNe-Hyp/001
- Acronym
- Botticelli
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2022
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05513937
- Acronym / sponsor ID
- Botticelli / MEIN/21/AmNe-Hyp/001
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Menarini International Operations Luxembourg SAIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol 5 mg | Active comparator | Drug: Nebivolol, Drug: AmlodipineMONOTHERAPY PHASE 4 weeks (Run-in from -4 week to week 0): patients will be treated with Nebivolol 5mg COMBINATION THERAPY PHASE 8 weeks (from week 0 to week 8): uncontrolled patients during Monotherapy Phase will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4). Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. |
| Amlodipine 5/10 mg | Active comparator | Drug: Nebivolol, Drug: AmlodipineMONOTHERAPY PHASE 4 weeks (Run-in from -4 week to week 0): patients will be treated with Amlodipine 5mg COMBINATION THERAPY PHASE 8 weeks (from week 0 to week 8): uncontrolled patients during Monotherapy Phase will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4). Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients with Grade 1 - 2 hypertension with mean sitting SBP ≥140 mmHg and ≤179 mmHg and/or mean sitting DBP ≥90 mmHg and ≤109 mmHg at screening (in accordance with the 2018 European Society of Cardiology / European Society of Hypertension guidelines definition), ≥18 and <65 years of age, on monotherapy treatment either with BBs or CCBs for at least 4 weeks before Visit 1 (screening).
- Patients are able to understand and have freely given written informed consent at Screening Visit.
- Patients who are able to comply with all study procedures and who are available for the duration of the study.
- Ability to take oral medication and willing to adhere to the drug regimen.
- Female patients are eligible to participate if not pregnant, or not breastfeeding and if they refrain from donating or storing eggs. For females of reproductive potential: use of highly effective contraception (eg. method of birth control throughout the study period and for 4 weeks after study completion defined as a method which results in a failure rate of <1% per year) such as:
Key exclusion criteria (19 listed)
- Patients with significant history of hypersensitivity to nebivolol, amlodipine, other BBs or other dihydropyridines, or any related products (including excipients of the formulations) as outlined in the relevant Investigators Brochures, summary of product characteristics12,13 or local package inserts for NEB and AML.
- 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.
- 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.
- Patients with condition of hypotension with SBP <90 mmHg and/or DBP <60 mmHg.
- Acute heart failure, cardiogenic shock, or episodes of heart failure decompensation requiring intravenous inotropic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NebivololTablets administered orally once daily according instructions provided by Principal Investigator. | Drug | Amlodipine 5/10 mg, Nebivolol 5 mg |
| AmlodipineTablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator. | Drug | Amlodipine 5/10 mg, Nebivolol 5 mg |
Primary outcome
Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8)
Time frame: From Visit 2 (week 0) to Visit 4 (week 8) for a total of 8 weeks
To assess the antihypertensive efficacy of the extemporaneous combination of Nebivolol (NEB) 5 mg in combination with Amlodipine (AML) 5 mg or AML 10 mg in lowering the sitting diastolic BP between Visit 2 (Week 0) and Visit 4 (Week 8) in patients with uncontrolled BP previously treated with Nebivolol or Amlodipine (5 mg) monotherapies for at least 4 weeks during run-in period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Volpe principal investigator
University "Sapienza" Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebivolol and Amlodipine in people with Hypertension, run by Menarini International Operations Luxembourg SA at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8) (time frame: From Visit 2 (week 0) to Visit 4 (week 8) for a total of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.