essential hypertension
Conditions
Sponsors
Boehringer Ingelheim Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. male or female patients aged at least 18 years at the time of informed consent. 2. diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated DBP = 95 mmHg if on existing antihypertensive treatment or seated DBP = 100 mmHg if treatment-naïve). 3. failure to respond to six weeks treatment with amlodipine 10mg monotherapy. (Failure to respond defined as seated DBP = 90 mmHg at six weeks. This criterion will be assessed at Visit 4.) 4. able to stop any current antihypertensive therapy without unacceptable risk to the patient 5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. pregnancy, breast-feeding or women of child-bearing potential who are not practising acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. 2. mean seated SBP = 200 mmHg and/or mean seated DBP = 120 mmHg at Visit 1 or at any time during run-in treatment or mean seated SBP = 180 mmHg and/or mean seated DBP = 120 mmHg at the randomisation visit (i.e. Visit 4) or at any time during the randomised treatment. 3. any clinically significant hepatic impairment 4. severe renal impairment, bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant. 5. clinically relevant hyperkalaemia. 6. uncorrected volume or sodium depletion. 7. primary aldosteronism. 8. hereditary fructose or lactose intolerance. 9. symptomatic congestive heart failure (New York Heart Academy functional class III-IV) 10. previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists. 11. history of drug or alcohol dependency within the previous six months. 12. concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form. 13. hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. 14. known allergic hypersensitivity to any component of the formulations under investigation. 15. non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period. 16. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator’s decision) by the start of the run-in period. 17. chronic administration of any medication known to affect blood pressure, other than the trial medication. 18. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that the combination of telmisartan (40 or 80mg) + amlodipine 10mg (A10) is superior to A10 monotherapy in reducing seated trough diastolic blood pressure (DBP) in patients who fail to respond to A10 monotherapy. ;Secondary Objective: (i) to show that the combination of telmisartan (40 or 80mg) + A10 is superior to A10 monotherapy in reducing seated trough systolic blood pressure (SBP) in patients who fail to respond to A10 monotherapy. (ii) to show that the combination of telmisartan (40 or 80mg) + A10 is superior to A10 monotherapy in reducing other blood pressure endpoints including proportion of patients achieving blood pressure control, DBP response and SBP response and proportions of patients with optimal, normal, high-normal and high blood pressure and (iii) to monitor safety through physical examinations, laboratory parameters, 12-lead electrocardiogram (ECG) and reported adverse events. The efficacy of the combination of telmisartan 40mg + amlodipine 10mg (T40/A10) will be compared with that of the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) for all endpoints ;Primary end point(s): The primary endpoint is the change from baseline in seated trough DBP (i.e. DBP approximately 24-hours after last dose of study treatment) after eight weeks of treatment or at last trough observation during the double-blind treatment period (i.e. last trough observation carried forward) | — |
Countries
Austria, Bulgaria, Czech Republic, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed