An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.
- Conditions
- Essential (primary) hypertension-I10 Essential (primary) hypertensionI10
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• The patient has essential hypertension (defined as a valley of the SBP, with the patient sitting, in the clinic between 150 and 180 mm Hg, inclusive, on Day -1 (day before Randomization) and average 24-hour SBP between 130 and 170 mm Hg, including on Day 1.
• The patient is a man or woman 18 years of age or older.
• A woman of reproductive age (that is, not sterilized and premenopausal) who is sexually active and agrees to use adequate contraception (as defined in the informed consent form) from the Selection and throughout the study.
• E! Patient presents clinical laboratory evaluations (including biochemistry, hematology and complete urinalysis) within the reference range of the laboratory performing the test or the investigator believes that the results are not clinically significant for inclusion in this study.
• The patient is willing to stop taking their antihypertensive medications during the Day Selection visit -21. If the patient was taking amlodipine before the Selection, he or she should be willing to discontinue this medication at the time of selection on Day -28.
• The patient presents a PAD valley, with the patient sitting in the clinic, greater than 114 mm Hg on Day -1 (day before Randomization)
• The patient has a baseline 24-hour MAP measurement of poor quality (as described in this protocol).
• The patient is taking or expected to take exclusive medications, as described in the Excluded Medications section.
• The patient has hypersensitivity to AII receptor blockers.
• The patient has a history of MI, heart failure, unstable angina, coronary artery bypass, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• The patient has clinically significant cardiac conduction defects (eg, third-degree atrio-ventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation, or atrial flutter).
• The patient has a hemodynamically significant left ventricular outflow obstruction due to aortic valve disease.
• The patient has secondary hypertension of any etiology (for example, renovascular disease, pheochromocytoma or Cushing´s syndrome).
• The patient does not comply (less than 70% or more than 130%) with taking the study medication during the run-in period with placebo.
• The patient has moderate to severe renal dysfunction or disease (confirmed by a calculation of creatinine clearance <30 mL / min / 1.73m2) at the time of selection.
• The patient presents or suspects stenosis of the unilateral or bilateral renal artery.
• The patient has a history of alcohol or drug abuse within the past 2 years.
• The patient has a history of cancer that is not in remission for at least 5 years before the first dose of the study medication. (This criterion does not apply to patients with basal cell carcinoma or squamous cell carcinoma of stage 1 skin).
• The patient has poorly controlled type 1 or type 2 diabetes mellitus (hemoglobin Ale> 8.0%) in the Selection.
• The patient presents hyperkalemia as defined by the normal reference ranges of the laboratory at the time of selection.
• The patient has alanine aminotransferase levels greater than 2.5 times the normal upper limit, active liver disease, or jaundice at the time of selection.
• The patient has a circumference of the upper arm less than 24 cm. or greater than 42 cm.
• The patient works during the night tumo (third tumor) [defined as from 11 PM (23:00) to 7 AM (07:00)].
• The patient does not want or can comply with the protocol or scheduled visits.
• The patient can not understand oral or written English or any other language of which there is a certified translation of the informed consent.
• The patient is an employee of the study center, or is an immediate family member (ie wife, father, mother, child, or sibling) of an employee of the study center who is involved in conducting this study.
• If you were a woman, you are pregnant, you want to get pregnant during the course of the study or you are breastfeeding.
• The patient is currently participating in another research study or has participated in a research study within 30 days prior to Randomization.
• The patient presents another disease or serious condition at the time of the Selection (or Randomization) that could compromise the patient´s safety, could affect their life expectancy, or make the follow-up or successful control of it, according to the protocol, be difficult.
• The patient has already been randomize
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:MAP is a non-invasive technology approved by the Food and Drug Administration (FDA) to measure BP over a period of at least 24 hours.<br>Measure:Change from the Basal value in the average PAS measured by MAP of 24 hours.<br>Timepoints:24 hours.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The MAPA device is programmed and calibrated by the investigator or designated to measure BP and heart rate at certain intervals during the day and night.<br>Measure:Average PAD of hours measured by MAPA of 24 hours.<br>Timepoints:24 hours.<br>;<br>Outcome name:The MAPA device is programmed and calibrated by the investigator or designated to measure BP and heart rate at certain intervals during the day and night.<br>Measure:PAS and PAD Valley with the patient sitting in the clinic<br>Timepoints:24 hours<br>;<br>Outcome name:Daytime average [6 AM to 10 PM], night average [12 AM to 6 AM], average BP at 0-12 hours after the dose, and average in the valley at 22 and 24 hours after the dose .<br>Measure:PAD and PAS using additional parameters of MAPA<br>Timepoints:22 and 24 hours after the dose .<br>;<br>Outcome name:AE, laboratory tests for safety, ECG and Vital signs.<br>Measure:Safety<br>Timepoints:During the study<br>