Filtered Trial for Telmisartan 40mg Non-responder

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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

  • Essential hypertensive patients who satisfying non-responder criteria
  • Male or Female
  • Age 20 years or older
  • Outpatient

Exclusion criteria

  • Taking four or more anti-hypertensive medications
  • Secondary hypertension
  • 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.
  • Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
  • Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
  • History of myocardial infarction or cardiac surgery within last 6 months
  • History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
  • History of unstable angina within last 3 months
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
  • History of stroke or transient ischemic attack within last 6 months
  • 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
  • Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
  • Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
  • Hepatic and/or renal dysfunction
  • Diagnosed biliary atresia or cholestasis
  • Hyperkalemia
  • Dehydration
  • Sodium deficiency
  • Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Patients who cannot change to the restricted administration and dosage during study period

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)
  • Drug or alcohol dependency
  • Complication of malignant tumour or a disease requiring immunosuppressants
  • Compliance of < 80% or > 120% during the run-in period
  • Receiving any investigational therapy within 3 months
  • Judged to be inappropriate by the investigator or the sub-investigator

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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