Filtered Trial for Amlodipine Non-responder

• Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
• Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
• Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
• Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks
• Percentage of Patients Who Achieved an Adequate Response, Defining Seated Trough Systolic Blood Pressure Was <140 mmHg or Decreased From Reference Baseline by >=20 mmHg at 8 Weeks in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
• Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

  Optimal, normal, high normal blood pressure were defined as follows:

  • Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP)
  • Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
  • High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg

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.

• Drug: telmisartan+amlodipine
• Drug: amlodipine

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