Trial · NCT05513937

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

NCT05513937, Phase 4, Completed, Menarini International Operations Luxembourg SA; results first posted 2025-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy. Trials, record NCT05513937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05513937

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy
NCT number: NCT05513937
Status: Completed
Phases: Phase 4
Enrollment: 301 participants, actual
Lead sponsor: Menarini International Operations Luxembourg SA
Conditions: Hypertension
Interventions: Nebivolol, Amlodipine
First posted: 2022-08-24
Last updated: 2025-02-04
Results first posted: 2025-02-04

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8)	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8)	From Visit 2 (week 0) to Visit 4 (week 8) for a total of 8 weeks	Primary endpoint (as per protocol assessed in patients who received combination therapy regardless of AML dose), is defined as mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)	mmHg	MEAN

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8)	Combination Therapy Phase Nebivolol 5mg/Amlodipine 5 or 10 mg		-15.2	Standard Deviation 8.32	mmHg

Source ClinicalTrials.gov

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run in (-4 Week to 0) Monotherapy Phase	STARTED	Run-In Nebivolol 5mg	143
Run in (-4 Week to 0) Monotherapy Phase	STARTED	Run-In Amlodipine 5mg	158
Run in (-4 Week to 0) Monotherapy Phase	STARTED	Combination Therapy Nebivolol 5mg/ Amlodipine 5mg	0
Run in (-4 Week to 0) Monotherapy Phase	STARTED	Combination Therapy Nebivolol 5mg/ Amlodipine 10mg	0
Run in (-4 Week to 0) Monotherapy Phase	COMPLETED	Run-In Nebivolol 5mg	139
Run in (-4 Week to 0) Monotherapy Phase	COMPLETED	Run-In Amlodipine 5mg	152
Run in (-4 Week to 0) Monotherapy Phase	COMPLETED	Combination Therapy Nebivolol 5mg/ Amlodipine 5mg	0
Run in (-4 Week to 0) Monotherapy Phase	COMPLETED	Combination Therapy Nebivolol 5mg/ Amlodipine 10mg	0
Run in (-4 Week to 0) Monotherapy Phase	NOT COMPLETED	Run-In Nebivolol 5mg	4
Run in (-4 Week to 0) Monotherapy Phase	NOT COMPLETED	Run-In Amlodipine 5mg	6

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events152

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Flushing	Vascular disorders	Nebivolo 5 mg MONOTHERAPY PERIOD	0	143
other	Flushing	Vascular disorders	Amlodipine 5 mg MONOTHERAPY PERIOD	0	158
other	Flushing	Vascular disorders	Nebivolo 5mg/Amlodipine 5 mg COMBINATION THERAPY PERIOD	1	279
other	Flushing	Vascular disorders	Nebivolo 5mg/Amlodipine 10mg COMBINATION THERAPY PERIOD	0	94
other	Feeling Hot	General disorders	Nebivolo 5 mg MONOTHERAPY PERIOD	0	143
other	Feeling Hot	General disorders	Amlodipine 5 mg MONOTHERAPY PERIOD	0	158
other	Feeling Hot	General disorders	Nebivolo 5mg/Amlodipine 5 mg COMBINATION THERAPY PERIOD	1	279
other	Feeling Hot	General disorders	Nebivolo 5mg/Amlodipine 10mg COMBINATION THERAPY PERIOD	1	94
other	Endometrial hyperplasia	Reproductive system and breast disorders	Nebivolo 5 mg MONOTHERAPY PERIOD	1	143
other	Endometrial hyperplasia	Reproductive system and breast disorders	Amlodipine 5 mg MONOTHERAPY PERIOD	0	158

1 to 10 of 152Source ClinicalTrials.gov

See all 152 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nebivolo 5 mg MONOTHERAPY PERIOD	0	143
Total, all-cause mortality	Amlodipine 5 mg MONOTHERAPY PERIOD	0	158
Total, all-cause mortality	Nebivolo 5mg/Amlodipine 5 mg COMBINATION THERAPY PERIOD	0	279
Total, all-cause mortality	Nebivolo 5mg/Amlodipine 10mg COMBINATION THERAPY PERIOD	0	94
Total, other adverse events	Nebivolo 5 mg MONOTHERAPY PERIOD	4	143
Total, other adverse events	Amlodipine 5 mg MONOTHERAPY PERIOD	2	158
Total, other adverse events	Nebivolo 5mg/Amlodipine 5 mg COMBINATION THERAPY PERIOD	35	279
Total, other adverse events	Nebivolo 5mg/Amlodipine 10mg COMBINATION THERAPY PERIOD	9	94
Total, serious adverse events	Nebivolo 5 mg MONOTHERAPY PERIOD	0	143
Total, serious adverse events	Amlodipine 5 mg MONOTHERAPY PERIOD	0	158

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05513937

GET https://conductscience.org/api/trials/v1/NCT05513937/flow?page=2

API reference For AI assistants