Filtered Trial for Telmisartan 40mg Non-Responder

Condition(s) targeted: Hypertension

Intervention: telmisartan+amlodipine (Drug); telmisartan (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage@boehringer-ingelheim.com

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.

Official title: Filtered Trial for Telmisartan 40mg Non-Responder

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

Primary outcome: 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.

Secondary outcome: Reduction in seated systolic blood pressure (SBP) Control rate in SBP/DBP Response rate in SBP/DBP Normalisation

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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 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

Boehringer Ingelheim Study Coordinator, Email: clintriage@boehringer-ingelheim.com

Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan; Recruiting

Boehringer Ingelheim Investigational Site, Chofu, Tokyo, Japan; Recruiting

Boehringer Ingelheim Investigational Site, Musashino, Tokyo, Japan; Recruiting

Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan; Recruiting

Boehringer Ingelheim Investigational Site, Hiroshima-shi, Hiroshima, Japan; Recruiting

Starting date: October 2007
Last updated: June 18, 2008