Filtered Trial for Telmisartan 40mg Non-responder

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Amlodipine; Telmisartan; Telmisartan amlodipine combination

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 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