Filtered Trial for Amlodipine Non-responder
Condition: Hypertension
MeSH terms: Hypertension
Intervention: 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: 531.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is
      superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately
      controlled with amlodipine 5 mg monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Essential hypertensive patients satisfying all of the following criteria;

          2. Male or Female

          3. Age > 20 years

          4. Outpatient

          5. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking
             any anti-hypertensive medications

          6. Patients with an ability to provide written informed consent in accordance with the
             related laws and guidelines such as Good Clinical Practice (GCP) and the
             Pharmaceutical Affairs Law.

        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