Status and phase
Conditions
Treatments
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
Sex
Ages
Volunteers
Inclusion criteria
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:
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
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Data sourced from clinicaltrials.gov
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