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Filtered Trial for Telmisartan 40mg Non-responder

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: telmisartan
Drug: telmisartan+amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550953
1235.14

Details and patient eligibility

About

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.

Enrollment

314 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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