essential hypertension
Conditions
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients aged at least 18 years at the date of signing the consent form 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study (inadequate control defined as seated DBP = 95 mmHg if on antihypertensive treatment or seated DBP = 100 mmHg if treatment naive) 3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy (defined as seated DBP = 90 mmHg at six weeks i.e. at Visit 3) 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. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. 2. known or suspected secondary hypertension 3. mean seated SBP = 200 mmHg and/or mean seated DBP = 120 mmHg at Visit 1 or 2 or mean seated SBP = 180 mmHg and/or mean seated DBP = 120 mmHg at the end of the run-in period (Visit 3) 4. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency) 5. severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 µmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.;Secondary Objective: (i) to show that the fixed dose combination of telmisartan (40 or 80mg) + A5 is superior to A5 monotherapy and not inferior to A10 monotherapy in reducing seated trough systolic blood pressure (SBP) in patients who do not respond adequately to A5 monotherapy. (ii) to show that the fixed dose combination of telmisartan (40 or 80mg) + A5 is superior to A5 monotherapy and not inferior 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 laboratory parameters, 12-lead electrocardiogram (ECG) and reported adverse events.;Primary end point(s): The co-primary endpoints are (a) the change from baseline in seated trough (i.e. at 24-hours after last dose) DBP after eight weeks of treatment or at last trough observation during the double-blind treatment period (i.e. last trough observation carried forward) and (b) the rate of incidence of oedema adverse events. | — |
Countries
Denmark, Finland, Netherlands, Sweden
Outcome results
None listed