essential hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: 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 at enrolment to the preceding trial 1235.6 (EudraCT 2007-002421-68). (Inadequate control defined as seated DBP = 95 mmHg if on existing antihypertensive treatment or seated DBP = 100 mmHg if treatment-naive.) 3. failure to respond to 6 weeks treatment with amlodipine 10mg monotherapy in the run-in period of the preceding trial 1235.6 (EudraCT 2007-002421-68). (Failure to respond defined as seated DBP = 90 mmHg.) 4. are randomised to the preceding trial 1235.6 (EudraCT 2007-002421-68) and have completed that trial in the 14 days prior to Visit 1. 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. development of any medical condition in the preceding 1235.6 trial (EudraCT 2007-002421-68) that in the investigator's opinion could be worsened by treatment with either T40/A10 or T80/A10. 3. discontinuation from the preceding 1235.6 trial (EudraCT 2007-002421-68) because of any adverse event or any other reason. 4. known or suspected secondary hypertension. 5. mean seated SBP = 180 mmHg and/or mean seated DBP = 120 mmHg at any visit. 6. any clinically significant hepatic impairment. 7. severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. 8. clinically relevant hyperkalaemia. 9. uncorrected volume or sodium depletion. 10. primary aldosteronism. 11. hereditary fructose or lactose intolerance. 12. symptomatic congestive heart failure (New York Heart Academy functional class III-IV). 13. patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin receptor blockers (ARBs). 14. any new occurrence of drug or alcohol dependency since signing the informed consent form of the preceding 1235.6 trial (EudraCT 2007-002421-68). 15. concurrent participation in another clinical trial or any investigational therapy since completion of the preceding 1235.6 trial (EudraCT 2007-002421-68). 16. hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. 17. known allergic hypersensitivity to any component of the formulations under investigation. 18. non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding 1235.6 trial( EudraCT 2007-002421-68) . 19. administration of ARBs or dihydropyridine calcium channel blockers at any time during the study (apart from trial medication). 20. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan or amlodipine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months. ;Secondary Objective: An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension. Efficacy endpoints include change in seated diastolic blood pressure (DBP) and systolic blood pressure (SBP), proportion of patients achieving DBP control, DBP response, SBP response and proportions of patients with optimal, normal, high-normal and high blood pressure. Safety will be monitored by assessment of laboratory parameters, 12-lead electrocardiogram (ECG) and reported adverse events. The efficacy and safety endpoints of T40/A10 will be compared with T80/A10. ;Primary end point(s): The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward). | — |
Countries
Austria, Bulgaria, Czech Republic, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed