Hypertension
Conditions
Brief summary
The primary objective of this study was test non-inferiority of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with predominantly systolic hypertension.
Interventions
DRUGTelmisartan 80 mg + hydrochlorothiazide 12.5 mg
DRUGAmlodipine 10 mg + hydrochlorothiazide 12.5 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged at least 60 years old * mean SBP greater than 140 mmHg and mean DBP less than or equal to 95 mmHg * 24-hour mean ambulatory SBP greater than 125 mmHg * hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks * willing and able to provide written informed consent
Exclusion criteria
* women of child-bearing potential who are NOT practicing acceptable means of birth control * known or suspected secondary hypertension * mean SBP equal to or greater than 200 mmHg * hepatic and/or renal dysfunction as defined by the following laboratory parameters: * bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney * clinically relevant hypokalemia or hyperkalemia * uncorrected volume or sodium depletion * primary aldosteronism * hereditary fructose intolerance * biliary obstructive disorders * patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists * history of drug or alcohol dependency within the previous six months * chronic administration of any medication known to affect blood pressure, other than the trial medication * concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form. * symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV) * unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent * stroke less than six months prior to informed consent * sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator * hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve * insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months * night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM * known allergic hypersensitivity to any component of the formulations under investigation * concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the run-in period * current treatment with any antihypertensive agent * any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit | 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period | week 8 and 14 |
| Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59)) | week 8 and 14 |
| Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index. | week 8 and 14 |
| Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM). | 8 weeks |
| Proportion of patients achieving a target response in SBP | 14 weeks |
| Change from baseline in DBP in the last six hours of the 24-hour dose period | week 8 and 14 |
| Proportion of patients achieving normal blood pressure | 14 weeks |
| Proportion of patients achieving high-normal blood pressure | 14 weeks |
| Change from baseline in trough seated SBP | 14 weeks |
| Change from baseline in trough seated DBP | 14 weeks |
| Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg | 14 weeks |
| Proportion of patients achieving SBP control | 14 weeks |
Countries
Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, South Africa, Spain
Outcome results
None listed