Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: 40 mg telmisartan; 5 mg amlodipine; 5 mg amlodipine; 80 mg telmisartan
Intervention description: once daily; once daily; once daily; once daily
Intervention MeSH terms: Amlodipine; Telmisartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 225.0
Sex: All
Minimum age: 20 Years

Summary:

      Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug
      alone, often a combination of two or more drugs is essential to achieve a sufficient
      antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination
      therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low
      dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the
      Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination
      (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure
      (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with
      T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.

      In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood
      pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination
      was shown (U07-3503-02). But the sponsor has no data that verifies this difference in
      Japanese patients.

      Thus, this clinical trial is being conducted to investigate the antihypertensive effect and
      safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients
      with essential hypertension. In this trial, a multi-centre, randomised, double-blind,
      double-dummy, active-controlled, parallel group comparison method is employed.
    

Eligibility criteria:

        Inclusion criteria:

          1. 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

          2. Able to stop all current antihypertensive drugs without risk to the patient based on
             the investigators opinion.

        Exclusion criteria:

          1. Patients taking 3 or more antihypertensive drugs at signing the informed consent form

          2. Patients with known or suspected secondary hypertension

          3. Patients with clinically relevant cardiac arrhythmia

          4. Congestive heart failure with New York Heart Association (NYHA) functional class
             III-IV

          5. Patients with recent cardiovascular events

          6. Patients with a history of stroke or transient ischaemic attack within last 6 months
             before signing the informed consent form

          7. 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

          8. 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

          9. Patients with known hypersensitivity to any component of the investigational product,
             or a known hypersensitivity to dihydropyridine-derived drugs

         10. Patients with hepatic and/or renal dysfunction

         11. Pre-menopausal women who are nursing or pregnant