Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertensio
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Patients with essential arterial hypertension (defined as a clinical FAS, valley, in a sitting position between 150 and 180 mm Hg inclusive, at Day -1 [day prior to randomization] and an average FAS in 24 hours between 130 mm Hg and 170 mm Hg (inclusive, to Day 1).
• The patient can be male or female> 18 years old.
• The patient has the ability to understand the requirements of the protocol and can meet them.
• The patient or his / her legal representative signs a written informed consent form before initiating any study procedure.
• Sexually active female patients of childbearing age (ie, not sterilized and premenopausal) must agree to use an adequate contraceptive method (as indicated on the informed consent form) from the selection period until the end of the study.
• The patient presents clinical laboratory evaluations (including clinical biochemistry, hematology, and complete urinalysis) within the reference range for laboratory tests or with results not considered clinically significant at the discretion of the investigator, so that the investigator can include the patient within the study.
• The patient is willing to suspend their current antihypertensive medications during the Day Selection visit -21. If the patient was in treatment with amlodipine before the Selection, the patient should discontinue this treatment in the Day -28 Selection.
• The patient has a valley FAD in the sitting position> 114 mm Hg at Day -1 (the day before randomization).
• The patient presents a 24-hour ambulatory blood pressure monitoring (MAFA) reading of insufficient quality at baseline (as defined in the protocol).
• The patient is receiving or expects to receive a medication that is excluded, as indicated in the excluded medications section, Section 7.3.
• The patient has hypersensitivity to angiotensin II receptor blockers (AII).
• The patient has a recent history (within the previous 6 months) of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack (TIA).
• The patient has clinically significant cardiac conduction abnormalities (eg, 3-degree atrioventricular block [AV], left bundle branch block [LBBB], sick sinus syndrome, atrial fibrillation, or flutter).
• The patient presents significant left ventricular outflow obstruction in hemodynamic terms due to aortic valve disease.
• The patient suffers from secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing´s syndrome).
• The patient does not comply with the treatment with the study drugs (compliance less than 70% greater than 130%) during the period of preparation with placebo.
• The patient has a severe renal dysfunction or renopathy (based on a calculation of creatinine clearance <30 mL / min / 1.73 m2) in the Selection.
• The patient has bilateral or unilateral confirmed or suspected stenosis of the renal artery.
• The patient has a history of alcoholism or drug addiction in the previous 2 years.
• The patient has a history of cancer without remission in the last 5 years before the first dose of the study drug. (This criterion does not apply to patients with basal cell carcinoma or squamous cell carcinoma in Stage 1).
• The patient suffers from diabetes mellitus type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin Ale [HbA1c]> 8.0%) in the Selection.
• The patient presents hyperkalemia, defined by the range of normal laboratory reference values in the Selection.
• The patient has a circumference of the upper arm less than 24 cm or greater than 42 cm.
• The patient works at night (defined as from 11 PM (or 23:00 hours) until 7 AM (or 7:00 AM).
• The patient has a concentration of alanine aminotransferase (ALT) greater than 2.5 times the normal upper limit value, active liver disease, or jaundice in the Selection.
• The patient is not willing or unable to comply with the protocol or scheduled appointments.
• The patient is unable to understand oral or written English, or any other language in which a certified translation of the approved informed consent is available.
• The patient is an employee of the study center, or is an immediate family member (eg, spouse, parent, child, henn / a) of an employee of the study center who is directly involved in conducting the study.
• If the patient is a woman, if she is pregnant, if she intends to become pregnant during the course of the study, or if she is breastfeeding.
• The patient is currently participating in another experimental study or has participated in an experimental study within 30 days prior to randomization.
• The patient suffers from any other serious disease or cond
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method