A study in multiple centres investigating the effect of two different active treatments for raised bloodpressure in elderly patients where it is unknown during the study which of both treatments is administered.

A multicentre randomised, double blind, active controlled, parallel group comparison of Nebivolol plus HCTZ and Irbesartan plus HCTZ in the treatment of isolated systolic hypertension in elderly patients. - The NEHIS Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023104-28-NL

Enrollment

150

Registered

2011-06-29

Start date

2011-10-20

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isolated Systolic Hypertension MedDRA version: 14.0 Level: LLT Classification code 10050591 Term: Isolated systolic hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Nebilet Plus Pharmaceutical Form: Capsule CAS Number: 152520-56-4 Other descriptive name: NEBIVOLOL HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female aged at least 60 years; • Office systolic blood pressure >140 mmHg and office diastolic blood pressure = 90 mmHg; • Subjects should have at least 2 additional risk factors • Willing to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: · Systolic blood pressure equal to or greater than 180 mmHg at the end of washout (visit 2) or run-in period (visit 3b); · Differences >20mmHg for SBP and >10mmHg for DBP on 3 consecutive readings at baseline · Current treatment with more than 2 antihypertensive agents within the last 6 months; · History of stroke, myocardial infarction, PCI or coronary bypass surgery within the last 12 months · Symptomatic lower limb ischemia i.e. claudicatio intermittens · Secondary hypertension (i.e.renovascular, adrenal, endocrine, tumor ..); · Serum creatinine > 150 µmol/L · Hepatic impairment defined as ASAT or ALAT >2 x upper normal limit; · Chronic administration of any medication known to affect blood pressure. · bradycardia (heart rate < 60 bpm prior to start therapy). · Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy; · Clinically significant ECG abnormalities at baseline. · Any other medical or mental condition or laboratory abnormality that makes the patient unsuitable for the study in the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ in term of SBP reduction after 12 weeks of treatment in elderly patients with isolated systolic hypertension.;Secondary Objective: To investigate the tolerability of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ.;Primary end point(s): The primary efficacy variable will be the change from baseline (Day 0) to the end of treatment (Day +84) in systolic blood pressure.;Timepoint(s) of evaluation of this end point: Day 84	—

Measure

Time frame

Main Objective: To demonstrate the superiority of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ in term of SBP reduction after 12 weeks of treatment in elderly patients with isolated systolic hypertension.;Secondary Objective: To investigate the tolerability of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ.;Primary end point(s): The primary efficacy variable will be the change from baseline (Day 0) to the end of treatment (Day +84) in systolic blood pressure.;Timepoint(s) of evaluation of this end point: Day 84

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Secondary

Measure	Time frame
Secondary end point(s): · To investigate the tolerability of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ. · Furthermore secondary efficacy criteria: · Percentage of normalized patients (mean SBP = 140 mmHg) at the end of treatment (Day +84); · Percentage of responding patients (decrease of mean SBP = 20 mmHg) at the end of treatment (Day +84); · Change from baseline to the end of treatment (Day +84) in the 24-hour mean SBP, measured by ABPM; · Change from baseline to the end of treatment (Day +84) in the 24-hour mean DBP, measured by ABPM; · Change from baseline to the end of treatment (Day +84) in SBP in the last six hours of the 24- hour dose period (as measured by 24-hour ABPM); · Change from baseline to the end of treatment (Day +84) in DBP in the last six hours of the 24- hour dose period (as measured by 24-hour ABPM); · Change from baseline to the end of treatment (Day +84) in SBP and DBP for other time intervals [i.e. daytime mean (06:00-00:00), and night-time mean (00:00-6:00)] (as measured by 24-hour ABPM). · Change from baseline to the end of treatment (Day +84) in arterial stiffness/distensibility · To investigate the effect of Nebivolol + HCTZ as compared to Irbesartan + HCTZ on the arterial stiffness parameters (details in section 24.2 (Appendix 2).;Timepoint(s) of evaluation of this end point: Day 84	—

Measure

Time frame

Secondary end point(s): · To investigate the tolerability of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ. · Furthermore secondary efficacy criteria: · Percentage of normalized patients (mean SBP = 140 mmHg) at the end of treatment (Day +84); · Percentage of responding patients (decrease of mean SBP = 20 mmHg) at the end of treatment (Day +84); · Change from baseline to the end of treatment (Day +84) in the 24-hour mean SBP, measured by ABPM; · Change from baseline to the end of treatment (Day +84) in the 24-hour mean DBP, measured by ABPM; · Change from baseline to the end of treatment (Day +84) in SBP in the last six hours of the 24- hour dose period (as measured by 24-hour ABPM); · Change from baseline to the end of treatment (Day +84) in DBP in the last six hours of the 24- hour dose period (as measured by 24-hour ABPM); · Change from baseline to the end of treatment (Day +84) in SBP and DBP for other time intervals [i.e. daytime mean (06:00-00:00), and night-time mean (00:00-6:00)] (as measured by 24-hour ABPM). · Change from baseline to the end of treatment (Day +84) in arterial stiffness/distensibility · To investigate the effect of Nebivolol + HCTZ as compared to Irbesartan + HCTZ on the arterial stiffness parameters (details in section 24.2 (Appendix 2).;Timepoint(s) of evaluation of this end point: Day 84

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Countries

Belgium, Netherlands

Contacts

Public ContactMarilena Grana

A. Menarini Farmaceutica Internazionale

mgrana@menarini.it003905556809993

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026