HypertensionPhase 4MasolinoNCT05279807

Effectiveness and Safety of Combination of Amlodipine and Zofenopril in Hypertensive Patients Versus Each Monotherapy

A Phase 4 study testing Zofenopril and Amlodipine in people with Hypertension, run by Menarini International Operations Luxembourg SA at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Zofenopril 30 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment in patients with uncontrolled BP previously treated with Zofenopril 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?: Zofenopril and Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 277 participants
Where: 1 siteHungary
Study dates: 15 Oct 2021to 28 Apr 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 Grade 1-2 hypertensive patients: with mean sitting SBP ≥140 mmHg and ≤179 mmHg and/or mean sitting DBP ≥ 90 mmHg and ≤109 mmHg at Screening, with ≥18 and ≤65 years of age, on monotherapy either with ZOF 30 mg or AML 5mg or any other ACE-I or CCBs (Felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, and nisoldipine) for at least 1 month before Visit 1 (Screening).
Patients who are able to understand and give written informed consent at Screening
Patients who are available for the entire trial period and willing to adhere to the protocol requirements
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 must refrain from donating or storing eggs. For females of reproductive potential: use of highly effective contraception (e.g., 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 less than 1% per year) such as:
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)

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Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner (performed at least 2 months before screening) (if 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

Known contraindications, presence of not recommended/contraindicated concomitant therapy allergies, or significant history of hypersensitivity to zofenopril, amlodipine, other ACE-inhibitors or dihydropyridines, or any related products including excipients of the formulations as outlined in the Investigator's Brochure (IB), or summary of product characteristics (SmPCs) or local package inserts for AML and ZOF
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, haematological, or oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients
Patients having a history of the following within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, bypass surgery, valve replacement (transcatheter aortic valve implantation, mitral-clip),cerebrovascular accident (stroke, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischemic attack. Patients with who have undergone other surgery that in the in the opinion of the Investigator may limit the ability to evaluate the efficacy or safety of the tested medications.
Patients with secondary hypertension of any aetiology such as renal diseases, pheochromocytoma, Cushing's syndrome hyperaldosteronism, renovascular disease, thyroid disorders
Patients with severe heart failure (New York Heart Association classification III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease
Patients with clinical evidence of renal disease as per the Investigator's judgement (including renovascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary kidney, or severe renal impairment)

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Patients with history of angioneurotic oedema
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)
Participation in any other interventional drug trial or exposure to other investigational agents within 30 days before Screening (Visit 1)
Inability to cooperate or any condition that, in the opinion of the Investigator, could increase the patient's risk of participating in the study or confound the outcome of the study
Patients with conditions that, in the opinion of the Investigator, would prevent a careful adherence to the protocol
Patients with severe hypotension
Patients who suffer from shock (including cardiogenic shock)
Patients treated with Amlodipine 10 mg and Zofenopril (other than 30 mg)

Trial locations and contacts

1 site in 1 country.

Hungary1 site

Investigational site
Debrecen, 4025

Other trials in Hungary

About this study

Official title: Interventional Clinical Trial to Assess Efficacy and Safety of the Extemporaneous Combination of Zofenopril Calcium and Amlodipine in Grade 1-2 Hypertensive Patients Versus Each Monotherapy - (MASOLINO Study)

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.

Patients with Grade 1-2 hypertensive patients (blood pressure [BP] ranging from ≥140/90 mmHg to ≤179/109 mmHg) on treatment with any angiotensin converting enzyme inhibitors (ACE-i) including Zofenopril (ZOF)30 mg or with calcium channel blockers (CCBs) including Amlodipine (AML)5 mg will be screened for eligibility (Visit 1).

Allowed CCBs: Felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, and nisoldipine. Patients treated with other dosages of ZOF (other than 30 mg) are not allowed to be screened. After screening, on the same day, eligible patients, will enter into a 4-week run-in period, during which patients on other ACE-i will be assigned to monotherapy with ZOF 30 mg while patients on CCBs will be assigned to monotherapy with AML 5 mg for 4 weeks. Patients with on-going treatment zofenopril 30 mg and amlodipine 5mg will continue on the same treatment for 4 weeks.

After the run-in period (4 weeks ± 2 days), BP will be further assessed (Visit 2), if BP levels are over the defined controlled target goal, sitting Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) >130/80 mmHg, treatment is well tolerated and adherence to the treatments ranges from 80% to 120%, patients will enter the assessment period, where they will be assigned to the extemporaneous combination of ZOF 30 mg and AML 5 mg. At Visit 2 patients with SBP/DBP values classified as Grade 3 (SBP ≥ 180 or DBP ≥ 110 mmHg) hypertension will be withdrawn from the study.

If patients, at Visit 2, after the run-in period, have a controlled BP (sitting SBP/DBP≤130/80 mmHg) or do not tolerate the treatment or have an adherence range below 80% or superior to 120%, they will be withdrawn from the study.

The patients will be assessed for further 8 weeks (assessment period). After 4 weeks ± 2 days from Visit 2,during the assessment period patients receiving the extemporaneous combination of ZOF 30 mg and AML 5 mg, will be further evaluated (Visit 3): controlled patients (sitting SBP/DBP ≤130/80 mmHg) will continue the same extemporaneous combination for additional 4 weeks ± 2 days, while uncontrolled patients (sitting SBP/DBP >130/80 mmHg) will be up-titrated from ZOF/AML 30/5 mg to ZOF/AML 30/10 mg for further 4 weeks ± 2 days. At Visit 3 patients with SBP/DBP values classified as Grade 3 (SBP ≥ 180 or DBP ≥ 110 mmHg) hypertension will be withdrawn from the study. If patients at Visit 3, do not tolerate the extemporaneous combination treatment or they have an adherence range below 80% or superior to 120%, they will be withdrawn from the study.

At the end of the assessment period (8 weeks ± 4 days) at Visit 4, the anti-hypertensive effect of the extemporaneous combination (ZOF/AML 30/5 mg and ZOF/AML 30/10 mg) will be evaluated.

Efforts will be made to achieve 1:1 ratio in the enrolment of patients receiving any ACE-i or allowed CCBs (refer to section Subject Study Phases Duration for allowed CCBs). At Visit 2, a minimum of 45% of uncontrolled patients receiving treatment with ZOF 30 mg or AML 5 mg are required to enter the assessment period, in order to maintain a balance between the 2 treatments during the assessment period.

Conditions: Hypertension
Being tested: Zofenopril, Amlodipine
Keywords: Hypertension, Combination Therapy, Zofenopril, Nebivolol, Fixed Dose Combination
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZofenoprilDrug
Film-Coated 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 groups in NCT05279807
Study group	Role	What they receive
Zofenopril 30 mg	Active comparator	Single dose Phase (4 weeks): patients will be treated with Zofenopril 30 mg. Combination Phase (8 weeks) uncontrolled patients will be treated with the extemporaneous combination of Zofenopril 30 mg and Amlodipine 5mg for 4 weeks. Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks while controlled patients with Zofenopril 30mg/Amlodipine 5mg will continue with the same therapy. Receives: Drug: Zofenopril; Drug: Amlodipine
Amlodipine 5/10 mg	Active comparator	Single dose Phase (4 weeks): patients will be treated with Amlodipine 5 mg. Combination Phase (8 weeks) uncontrolled patients will be treated with the extemporaneous combination of Zofenopril 30 mg and Amlodipine 5mg for 4 weeks. Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks while controlled patients with Zofenopril 30mg/Amlodipine 5mg will continue with the same therapy. Receives: Drug: Zofenopril; 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 Zofenopril (ZOF) 30 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 Zofenopril 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.

15 Oct 202128 Apr 2022

First posted15 Mar 2022
Study start15 Oct 2021
Primary completion28 Apr 2022
Study completion28 Apr 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
Model description: Patients with uncontrolled BP on treatment with any Ace-i or any CCB, if eligible, will enter a 4-week run-in period. Patients will then be all assigned to mono-therapy with ZOF 30mg or AML 5mg for 4 weeks if in treatment with Ace-i or CCB respectively. At Visit 2 patients with uncontrolled BP, tolerating treatment and with adherence within 80%/120% ranges, will receive extemporaneous combination ZOF 30mg+AML 5mg, while patients with controlled BP, tolerating treatment or with adherence out of 80%/120% range, will be withdrawn from the study together with patients with SBP/DBP ≥ 180/100 mmHg. At Visit 3 (Visit 2 + 4 weeks ± 2 days) controlled patients will continue extemporaneous combination for additional 4 weeks ± 2 days, while uncontrolled patients will be up-titrated to ZOF 30mg/AML 10mg for the same time. Patients with SBP/DBP ≥ 180/100 mmHg or not tolerating extemporaneous combination or with adherence out of 80%/120% range, will be withdrawn from the study.
Masking: None (open label)
Enrolment: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05279807
Sponsor's protocol ID: MEIN/20/ZoAm-Hyp/001
Acronym: Masolino
Status last verified: Aug 2022
First submitted: 4 Mar 2022
Last updated: 21 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional Clinical Trial to Assess Efficacy and Safety of the Extemporaneous Combination of Zofenopril Calcium and Amlodipine in Grade 1-2 Hypertensive Patients Versus Each Monotherapy - (MASOLINO Study)
ClinicalTrials.gov ID: NCT05279807
Acronym / sponsor ID: Masolino / MEIN/20/ZoAm-Hyp/001
Conditions: Hypertension
Keywords: Hypertension, Combination Therapy, Zofenopril, Nebivolol, Fixed Dose Combination
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Menarini International Operations Luxembourg SAIndustry (pharma, biotech, devices)
Study start: 15 Oct 2021 (actual)
Primary completion: 28 Apr 2022 (actual)
Study completion: 28 Apr 2022 (actual)
First posted: 15 Mar 2022 (actual)
Results: Posted 21 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

At the end of the assessment period (8 weeks ± 4 days) at Visit 4, the anti-hypertensive effect of the extemporaneous combination (ZOF/AML 30/5 mg and ZOF/AML 30/10 mg) will be evaluated.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Patients with uncontrolled BP on treatment with any Ace-i or any CCB, if eligible, will enter a 4-week run-in period. Patients will then be all assigned to mono-therapy with ZOF 30mg or AML 5mg for 4 weeks if in treatment with Ace-i or CCB respectively. At Visit 2 patients with uncontrolled BP, tolerating treatment and with adherence within 80%/120% ranges, will receive extemporaneous combination ZOF 30mg+AML 5mg, while patients with controlled BP, tolerating treatment or with adherence out of 80%/120% range, will be withdrawn from the study together with patients with SBP/DBP ≥ 180/100 mmHg. At Visit 3 (Visit 2 + 4 weeks ± 2 days) controlled patients will continue extemporaneous combination for additional 4 weeks ± 2 days, while uncontrolled patients will be up-titrated to ZOF 30mg/AML 10mg for the same time. Patients with SBP/DBP ≥ 180/100 mmHg or not tolerating extemporaneous combination or with adherence out of 80%/120% range, will be withdrawn from the study.

Arm	Type	Receives
Zofenopril 30 mg	Active comparator	Drug: Zofenopril, Drug: AmlodipineSingle dose Phase (4 weeks): patients will be treated with Zofenopril 30 mg. Combination Phase (8 weeks) uncontrolled patients will be treated with the extemporaneous combination of Zofenopril 30 mg and Amlodipine 5mg for 4 weeks. Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks while controlled patients with Zofenopril 30mg/Amlodipine 5mg will continue with the same therapy.
Amlodipine 5/10 mg	Active comparator	Drug: Zofenopril, Drug: AmlodipineSingle dose Phase (4 weeks): patients will be treated with Amlodipine 5 mg. Combination Phase (8 weeks) uncontrolled patients will be treated with the extemporaneous combination of Zofenopril 30 mg and Amlodipine 5mg for 4 weeks. Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks while controlled patients with Zofenopril 30mg/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 Grade 1-2 hypertensive patients: with mean sitting SBP ≥140 mmHg and ≤179 mmHg and/or mean sitting DBP ≥ 90 mmHg and ≤109 mmHg at Screening, with ≥18 and ≤65 years of age, on monotherapy either with ZOF 30 mg or AML 5mg or any other ACE-I or CCBs (Felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, and nisoldipine) for at least 1 month before Visit 1 (Screening).
Patients who are able to understand and give written informed consent at Screening
Patients who are available for the entire trial period and willing to adhere to the protocol requirements
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 must refrain from donating or storing eggs. For females of reproductive potential: use of highly effective contraception (e.g., 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 less than 1% per year) such as:

Key exclusion criteria (16 listed)

Known contraindications, presence of not recommended/contraindicated concomitant therapy allergies, or significant history of hypersensitivity to zofenopril, amlodipine, other ACE-inhibitors or dihydropyridines, or any related products including excipients of the formulations as outlined in the Investigator's Brochure (IB), or summary of product characteristics (SmPCs) or local package inserts for AML and ZOF
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, haematological, or oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients
Patients having a history of the following within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, bypass surgery, valve replacement (transcatheter aortic valve implantation, mitral-clip),cerebrovascular accident (stroke, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischemic attack. Patients with who have undergone other surgery that in the in the opinion of the Investigator may limit the ability to evaluate the efficacy or safety of the tested medications.
Patients with secondary hypertension of any aetiology such as renal diseases, pheochromocytoma, Cushing's syndrome hyperaldosteronism, renovascular disease, thyroid disorders
Patients with severe heart failure (New York Heart Association classification III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease

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
ZofenoprilFilm-Coated tablets administered orally once daily according instructions provided by Principal Investigator.	Drug	Amlodipine 5/10 mg, Zofenopril 30 mg
AmlodipineTablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator.	Drug	Amlodipine 5/10 mg, Zofenopril 30 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 Zofenopril (ZOF) 30 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 Zofenopril or Amlodipine (5 mg) monotherapies for at least 4 weeks during run-in period.

Results and safety

Results posted to the registry on 21 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zofenopril 30mg	144	142
Amlodipine 5/10 mg	133	132

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. Mean (Standard Deviation). Unit: mmHg

Measure	Combination Therapy Phase Zofenopril 30mg/Amlodipine 5 or 10 mg n = 269
Value	-13.5 (8.31)

Combination Therapy Phase Zofenopril 30mg/Amlodipine 5 or 10 mg: Mean difference pre vs post treatment: -13.5 (95% CI -14.5 to -12.5), p < 0.001, Paired Samples T-Test

Population analysed: Efficacy Population: all study participants who signed inform consent, met all screening criteria, were enrolled and received at least one dose of the assigned treatment during the run-in period and completed the 4-week run-in period, who met criteria at Visit 2 (Week 0) \[uncontrolled BP (sitting Systolic BP/DBP \> 130 / 80 mmHg)\], tolerated treatment, had treatment adherence between 80 - 120 % and had at least one available post baseline primary efficacy assessment.

Adverse events

Time frame: From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zofenopril 30mg MONOTHERAPY PERIOD	0 of 143 (0%)	8 of 143 (5.6%)	0 of 143
Amlodipine 5 mg MONOTHERAPY PERIOD	0 of 133 (0%)	11 of 133 (8.3%)	0 of 133
Zofenopril 30mg/Amlodipine 5mg COMBINATION THERAPY PERIOD	0 of 149 (0%)	10 of 149 (6.7%)	0 of 149
Zofenopril 30mg/Amlodipine 10mg COMBINATION THERAPY PERIOD	1 of 122 (0.8%)	20 of 122 (16.4%)	0 of 122

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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, Professor 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 Zofenopril and Amlodipine in people with Hypertension, run by Menarini International Operations Luxembourg SA at 1 site in Hungary.

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 16 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 21 Oct 2024. 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 Hungary. 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 21 Oct 2024). 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?

On the ClinicalTrials.gov record for NCT05279807.

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 21 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.