Official Title: “Filtered Trial for Amlodipine Non-Responder”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

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

Primary Measures

• The primary endpoint is the reduction from reference baseline in mean seated diastolic blood pressure (DBP) at trough (24 hour post dosing) 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 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 DBP > 114 mmHg and/or mean seated 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 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  

Overall Contact: Boehringer Ingelheim Study Coordinator  clintriage@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00558064

Study ID Number: 1235.13

ClinicalTrials.gov Identifier: NCT00558064

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