Official Title: “Filtered Trial for Telmisartan 40mg Non-Responder”

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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: telmisartan+amlodipine
  • T40mg/A5mg/day
• Drug: telmisartan
  • T40mg/day

Primary Measures

• The primary endpoint is the reduction from reference baseline in mean seated diastolic blood pressure (DBP) at trough (24hr postdosing) after 8 weeks of the double blind treatment.
  • Time Frame: 8 Weeks
    

Secondary Measures

• Reduction in seated systolic blood pressure (SBP) Control rate in SBP/DBP Response rate in SBP/DBP Normalisation
  • Time Frame: 8 Weeks
    

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 DBP > 114 mmHg and/or mean seated SBP > 200 mmHg during run-in, or less than 90 mmHg in DBP during T40 mg monotherapy
• 4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
• 5. Congestive heart failure patients with 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 ARBs or 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 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):
• 1) Pregnant or possibly pregnant 2) Nursing 3) Desire to become pregnant during study period 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00550953

Study ID Number: 1235.14

ClinicalTrials.gov Identifier: NCT00550953

Health Authority: Japan: Ministry of Health, Labor and Welfare