Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: fixed dose combination of telmisartan+amlodipine; amlodipine
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 947.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to demonstrate that the fixed dose combination of
      telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan
      80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks
      compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks
      treatment with A10.
    

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.