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.

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. - The NEHIS study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36031

Enrollment

Registered

2011-06-24

Start date

2011-11-17

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

isolated systolic hypertension / isolated elevated systolic bloodpressure

Interventions

Once daily Nebivolol 5 mg/HCTZ 12.5 mg or Irbesartan 150 mg/HCTZ 12.5 mg for 12 weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Male or female aged at least 60 years; • Office systolic blood pressure >140 mmHg and office diastolic blood pressure

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

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable will be the change from baseline (Day 0) to the end of treatment (Day +84) in systolic blood pressure.	—

Secondary

Measure	Time frame
Percentage of normalized patients (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). ABPM readings will be read and evaluated centrally.	—

Measure

Time frame

Percentage of normalized patients (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). ABPM readings will be read and evaluated centrally.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)