To demonstrate the superiority of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ in terms of SBP reduction after 12 weeks of treatment in elderly patients with isolated systolic hypertension.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy variable will be the change from baseline (Day 0) to the
end of treatment (Day +84) in systolic blood pressure.
Secondary outcome
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).
ABPM readings will be read and evaluated centrally.
Background summary
Isolated Systolic hypertension is a common and particularly poorly controlled
form of hypertension and is a strong predictor of cardiovascular morbidity and
mortality.
Encouraging long-term data from clinical trials strongly support the usefulness
of adequate antihypertensive treatment in elderly patients with isolated
systolic hypertension. Indeed most of patients do not reach an adequate blood
pressure control with monotherapy and require a combination therapy with two
different antihypertensive agents.
Nebivolol is a novel cardio selective beta-1 blocker with vasodilating
properties.
Irbesartan is a recent ATII receptor antagonist; clinical data have
demonstrated the efficacy of this drug on blood pressure control, especially
isolated systolic blood pressure.
The present study aims to demonstrate superiority of the combination Nebivolol
+ Hydrochlorothiazide as compared to the combination Irbesartan +
Hydrochlorothiazide.
Study objective
To demonstrate the superiority of the combination Nebivolol plus HCTZ versus
Irbesartan plus HCTZ in terms of SBP reduction after 12 weeks of treatment in
elderly patients with isolated systolic hypertension.
Study design
Double-blind randomised 2 parallel groups study
Intervention
Once daily Nebivolol 5 mg/HCTZ 12.5 mg or Irbesartan 150 mg/HCTZ 12.5 mg for 12
weeks.
Study burden and risks
There is a slight risk of pain or bruising and infection when blood is drawn
for laboratory tests.
None of the other study procedures are associated with any clinically
significant risks.
Subjects may experience a slight discomfort during the 24-h bloodpressure
registration, at times the cuff is inflated.
Possible side effects of Irbesartan are tiredness, dizziness, gastro-intestinal
complaints (nausea/vomiting and to a much lesser extend diarrhoea,
dyspepsia/heartburn).
Possible side effects of Nebivolol: Headache, dizziness, tiredness and
paraesthesia are the most common side effect in clinical studies. Up till 10%
of the patients experienced the following side effects: dyspnoe, constipation,
nausea, diarrhoea and oedema.
The most common side effects of Hydrochlorothiazide are hypokalaemia, dry
mouth, tiredness, muscle cramps, dizziness, gout, worsening of pre-existing
diabetes, thrombocytopenia.
1, Avenue de la Gare
L-1611 Luxembourg
LU
1, Avenue de la Gare
L-1611 Luxembourg
LU
Listed location countries
Age
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.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023104-28-NL |
| CCMO | NL35854.028.11 |