Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

Launched by BOEHRINGER INGELHEIM · Nov 2, 2007

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Eligibility criteria

• Inclusion Criteria:
• • diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) \>= 95 mmHg if on existing antihypertensive treatment or seated DBP \>= 100 mmHg if treatment-naïve).
• • failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP \>= 90 mmHg.)
• • able to stop any current antihypertensive therapy without unacceptable risk to the patient.
• • willing and able to provide written informed consent.
• Exclusion Criteria:
• • pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
• • known or suspected secondary hypertension.
• • mean seated systolic blood pressure (SBP) \>=200 mmHg and/or mean seated DBP \>= 120 mmHg during run-in treatment or mean seated SBP \>= 180 mmHg and/or mean seated DBP \>= 120 mmHg at the randomisation visit or at any time during randomised treatment.
• • any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
• • clinically relevant hyperkalaemia.
• • uncorrected volume or sodium depletion.
• • primary aldosteronism.
• • hereditary fructose or lactose intolerance.
• • symptomatic congestive heart failure.
• • patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs.
• • history of drug or alcohol dependency within the six months prior to signing consent.
• • concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.
• • 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 ARBs or amlodipine or other dihydropyridine CCBs.)
• • non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.
• • current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.
• • chronic administration of any medication known to affect blood pressure, other than the trial medication.
• • any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.