Filtered Trial for Amlodipine Non-responder

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: telmisartan+amlodipine; Drug: amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00558064

1235.13

Details and patient eligibility

About

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.

Enrollment: 531 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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