A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmHg and ≤ 109 mmHg, measured by manual cuff sphygmomanometer, at Visit 3 (baseline cuff BP)
A 24-mean DBP of ≥ 85 mmHg at Visit 4 as measured by ABPM
Age 18 years or older
Ability to stop current antihypertensive therapy without risk to the patient (investigator's discretion)
Patient's written informed consent in accordance with good clinical practice (GCP) and local legislation
You may not be if
Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
* are not surgically sterile; and/or
* are nursing
* are of child-bearing potential and are NOT practising acceptable means of birth control, do NOT plan to continue using this method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives
Known or suspected secondary hypertension
Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the placebo run-in period
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* Serum glutamate-pyruvate-transaminase (alanine aminotransferase) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) \> than 2 times the upper limit of normal range
Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; patients post-renal transplant or with only one kidney
Clinically relevant sodium depletion, hypokalaemia, or hyperkalaemia
Uncorrected volume depletion
Primary aldosteronism
Hereditary fructose intolerance
Biliary obstructive disorders
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
History of drug or alcohol dependency within 6 months
Chronic administration of any medications known to affect blood pressure, except medications allowed by the protocol
Any investigational therapy within one month of signing the informed consent form
Congestive heart failure (NYHA functional class congestive heart failure (CHF) class III-IV)
Unstable angina within the past six months
Stroke within the past six months
Myocardial infarction or cardiac surgery within the past six months
Percutaneous transluminal coronary angioplasty (PTCA) within the past six months
Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients with insulin-dependent diabetes mellitus whose diabetes hast not been stable and controlled for at least the past three months as defined by an HbA1c ≥ 10%
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (AM)
Known hypersensitivity to any component of the formulations
Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
Clareo Health | A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
