essential hypertension
Conditions
Interventions
Trade Name: Micardis HCT 80/25
Pharmaceutical Form: Tablet
INN or Proposed INN: telmisartan
Current Sponsor code: BIBR 277
Concentration
Sponsors
Boehringer Ingelheim Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients aged at least 18 years. diagnosis of essential hypertension (as defined in JNC-7; P03-04405) and taking between one and three antihypertensive medications at a stable dose for at least four weeks before entry to the preceding trial 502.480. blood pressure not adequately controlled on existing antihypertensive treatment before entry to the preceding trial 502.480 . have been shown not to respond to six weeks treatment with T80/H12.5 in the preceding trial 502.480. (Failure to respond defined as seated DBP = 90 mmHg.) are randomised to the preceding trial 502.480 and have completed that trial in the fourteen (14) days prior to Visit 1. 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: women of child-bearing potential who are NOT practising acceptable means of birth control or do NOT plan to continue using acceptable means of birth control throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives. women with a positive serum pregnancy test at Visit 1 or at any subsequent visit. women who are breastfeeding. clinically significant change in ECG from baseline that is reported as an adverse event in the preceding 502.480 trial. development of any medical condition in the preceding 502.480 trial that in the investigator's opinion could be worsened by treatment with T80/H25. discontinuation from the preceding 502.480 trial because of any adverse event or any other reason. known or suspected secondary hypertension. mean SBP equal to or greater than 200 mmHg at any visit. severe hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorders or hepatic insufficiency). severe renal impairment (known creatinine clearance < 30 mL/min or clinical markers of severe renal impairment). bilateral renal artery stenosis or 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. 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 more recent than six months before entry to the preceding 502.480 trial. concurrent participation in another clinical trial or any investigational therapy at any time after thirty days prior to signing the consent form for the preceding 502.480 trial. hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other angiotensin-II receptor antagonists or hydrochlorothiazide or sulphonamide-derived drugs.) concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding 502.480 trial. 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 hydrochlorothiazide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy and safety of the high-strength fixed dose combination of telmisartan 80 mg + HCTZ 25 mg (T80/H25) during open-label, long-term treatment. ;Secondary Objective: An additional objective is to assess the efficacy and safety of concomitant administration of the high-strength fixed dose combination of telmisartan 80mg + HCTZ 25 mg 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, Germany, Ireland, Italy, Norway, Spain, Sweden
Outcome results
None listed