Filtered Trial for Telmisartan 40mg Non-responder
Condition: Hypertension
MeSH terms: Hypertension
Intervention: telmisartan+amlodipine; telmisartan
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 314.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to:

      Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is
      superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately
      controlled with telmisartan 40 mg monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Essential hypertensive patients who satisfying non-responder criteria

          2. Male or Female

          3. Age 20 years or older

          4. Outpatient

        Exclusion Criteria:

          1. Taking four or more anti-hypertensive medications

          2. Secondary hypertension

          3. Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic
             blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg
             at Visit 3.

          4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias

          5. Congestive heart failure patients with the New York Heart Association (NYHA)
             functional class III-IV

          6. History of myocardial infarction or cardiac surgery within last 6 months

          7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI)
             within last 3 months

          8. History of unstable angina within last 3 months

          9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant
             stenosis of aortic or mitral valve

         10. History of stroke or transient ischemic attack within last 6 months

         11. History of sudden exacerbation of renal function with angiotensin II receptor blockers
             (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal
             transplant or post-nephrectomy

         12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE
             inhibitors

         13. Known hypersensitivity to any component of the investigational drug , or a known
             hypersensitivity to dihydropyridine -derived drugs

         14. Hepatic and/or renal dysfunction

         15. Diagnosed biliary atresia or cholestasis

         16. Hyperkalemia

         17. Dehydration

         18. Sodium deficiency

         19. Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs
             (NSAIDs)

         20. Patients who cannot change to the restricted administration and dosage during study
             period

         21. Pre-menopausal women who meet any one of the following 1 - 3:

               -  Pregnant or possibly pregnant (1)

               -  Nursing (2)

               -  Desire to become pregnant during study period (3)

         22. Drug or alcohol dependency

         23. Complication of malignant tumour or a disease requiring immunosuppressants

         24. Compliance of < 80% or > 120% during the run-in period

         25. Receiving any investigational therapy within 3 months

         26. Judged to be inappropriate by the investigator or the sub-investigator