A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® (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.
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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, on the last visit (Visit 6) of the four-week placebo run-in period (baseline BP). The manual cuff value is calculated as the mean of three seated measurements taken two minutes apart, after the patient has been seated quietly for 5 minutes
A 24-mean DBP of ≥ 85 mmHg at Visit 7 as measured by ABPM
Age 18 years or older
Ability to stop current antihypertensive therapy without risk to the patient (investigator's discretion)
Ability to provide written informed consent
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 practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of ≥ 3-months duration. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
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) greater than two times the upper limit of normal
* Serum creatinine \> 2.3 mg/dL
Clinically relevant sodium depletion, hyperkalemia, or hypokalemia
Uncorrected volume depletion
Primary aldosteronism
Biliary obstructive disorders
Known or suspected secondary hypertension
Hereditary fructose intolerance
Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
Congestive heart failure (NYHA functional class congestive heart failure (CHF) class III-IV)
Unstable angina within the past three months
Stroke within the past six months
Myocardial infarction or cardiac surgery within the past three months
Percutaneous transluminal coronary angioplasty (PTCA) within the past three months
History of angioedema
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%
Known drug or alcohol dependency within the past 6 months
Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridien (AM)
Patients receiving any investigational therapy within one month of signing the informed consent form
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® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
