Telmisartan 80mg Non-responder Trial
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Telmisartan and amlodipine; Telmisartan
Intervention description: Telmisartan 80 mg and amlodipine 5 mg once a daily; 80 mg once a daily
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 174.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an
      antihypertensive drug from different class should be started concomitantly.

      In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential
      hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg,
      the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg
      monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan
      80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her
      blood pressure controlled with telmisartan 80 mg.

      Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and
      safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different
      pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with
      telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who
      fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg
      monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy,
      active-controlled, parallel group comparison method is employed.
    

Eligibility criteria:

        Inclusion criteria:

          -  Essential hypertensive patients

               -  If already taking antihypertensive drugs, mean seated diastolic blood pressure
                  (DBP) must be >=90 and >=114 mmHg

               -  If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114
                  mmHg

          -  Able to stop all current antihypertensive drugs without risk to the patient based on
             the investigators opinion.

        Exclusion criteria:

          -  Patients taking 3 or more antihypertensive drugs at signing the informed consent form

          -  Patients with known or suspected secondary hypertension

          -  Patients with clinically relevant cardiac arrhythmia

          -  Congestive heart failure with New York Heart Association (NYHA) functional class
             III-IV

          -  Patients with recent cardiovascular events

          -  Patients with a history of stroke or transient ischaemic attack within last 6 months
             before signing the informed consent form

          -  Patients with a history of sudden deterioration of renal function with angiotensin II
             receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or
             patients with post-renal transplant or post-nephrectomy

          -  Patients who have previously experienced characteristic symptoms of angioedema (such
             as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment
             with ARBs or ACE inhibitors

          -  Patients with known hypersensitivity to any component of the investigational product,
             or a known hypersensitivity to dihydropyridine-derived drugs

          -  Patients with hepatic and/or renal dysfunction

          -  Pre-menopausal women who are nursing or pregnant