A prospective randomised study to compare a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in patients with uncontrolled hypertension who fail to respond adequately to treatment with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg.

Boehringer Ingelheim Finland Ky0 sites1,600 target enrollmentAugust 30, 2005

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2005

End Date

August 3, 2006

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•male or female patients aged at least 18 years.
•diagnosis of essential hypertension and currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before entry.
•blood pressure not adequately controlled on existing antihypertensive treatment before entry. (Inadequate control defined as seated DBP \= 95 mmHg on one current antihypertensive medication or DBP \= 90 mmHg on two or more current antihypertensive medications).
•failure to respond to six weeks treatment with T80/H12\.5 fixed\-dose combination therapy. (Failure to respond defined as seated DBP \= 90 mmHg at six weeks.)
•willing and able to provide written informed consent
•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

•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 entry or at any subsequent visit or women who are breast\-feeding.
•known or suspected secondary hypertension.
•mean SBP equal to or greater than 200 mmHg at the end of the run\-in treatment period.
•severe hepatic or renal impairment (including bilateral renal artery stenosis, renal artery stenosis in a solitary kidney or patients post\-renal transplant or with only one functioning kidney)
•clinically relevant hypokalaemia or hyperkalaemia.
•uncorrected volume or sodium depletion.
•primary aldosteronism.
•hereditary fructose intolerance.
•patients who have previously experienced symptoms characteristic of angioedema during treatment with any ACE inhibitors or angiotensin\-II receptor antagonist.