essential hypertension MedDRA version: 9.1 Level: PT Classification code 10015488 Term: Essential hypertension
Conditions
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients aged at least 18 years 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial 1235.5 (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 six weeks treatment with A5 in the run-in period of the preceding trial 1235.5 (failure to respond defined as seated DBP = 90 mmHg) 4. are randomised to the preceding trial 1235.5 and have completed that trial in the fourteen (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. 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. development of any medical condition in the preceding 1235.5 trial that in the investigator's opinion could be worsened by treatment with either T40/A5 or T80/A5 3. discontinuation from the preceding 1235.5 trial 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 (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency) 7. severe renal impairment (e.g. serum creatinine > 3.0 mg/dl or > 265 µmol/L, known creatinine clearance < 30 mL/min or clinical markers of severe renal impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A5 or T80/A5 during long-term open-label treatment.;Secondary Objective: An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A5 or T80/A5 with any other therapies commonly used in the treatment of hypertension.;Primary end point(s): The primary endpoint is the proportion of patients achieving diastolic blood pressure (DBP) control (defined as mean seated DBP < 90 mmHg at trough i.e. 24 hours after last dose) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward). | — |
Countries
Denmark, Finland, France, Netherlands, Sweden
Outcome results
None listed