26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: fixed-dose combination of telmisartan 40mg+amlodipine 10mg; fixed-dose combination of telmisartan 80mg+amlodipine10mg
Intervention MeSH terms: Amlodipine; Telmisartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Enrollment: 838.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to assess the efficacy and safety of the fixed dose
      combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg
      (T80/A10) during open-label treatment for at least six months.

      An additional objective is to assess the efficacy and safety of concomitant administration of
      either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of
      hypertension.

      The primary endpoint is the proportion of patients achieving DBP control (defined as mean
      seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study
      treatment) at six months of treatment or at last trough observation during the treatment
      period (i.e. last trough observation carried forward).
    

Eligibility criteria:

        Inclusion Criteria:

        - diagnosis of essential hypertension

        Exclusion Criteria:

          -  pregnancy, breast-feeding, unwilling to use effective contraception (if female of
             child-bearing potential).

          -  development of any condition in the preceding trial that could be worsened by
             telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg
             (T80/A10).

          -  discontinuation from the preceding trial.

          -  known or suspected secondary hypertension.

          -  mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic
             blood pressure (DBP) >= 120 mmHg at any visit.

          -  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 angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor
             blockers (ARBs).

          -  any new drug or alcohol dependency since signing consent of the preceding trial.

          -  concurrent participation in another clinical trial or any investigational therapy
             since completing the preceding 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 ARBs or
             amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance
             with study medication (defined as <80% or >120%) during the preceding trial.

          -  administration of ARBs or dihydropyridine CCBs (apart from 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.