None listed
Conditions
Interventions
Group 1 Type of group
20 mg of TAK-491 with adjustment to 40 mg QD orally for 6 months
Group name:Group 3 Type of group
80 mg of valsartan with adjustment to 320 mg QD orally for 6 months
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:obtained by ambulatory blood pressure monitoring (ABPM). Measure:change from baseline time in the average SBP for 24 hours Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:obtained by ambulatory blood pressure monitoring (ABPM). Measure:change from the basal time in the average DBP for 24 hours Timepoints:6 weeks ; Outcome name:the change from baseline time in the SBP and PAD minimum clinics in sitting. Measure:the change from baseline time in the SBP and PAD minimum clinics in sitting. Timepoints:6 weeks ; Outcome name:(including average daytime value [6 AM to 10 PM], average night value [12 AM to 6 AM], mean BP from O to 12 hours after the dose, average value in the valley from 22 to 24 hours after the dose , peak effect, and ratio of minimum value to peak value). Measure:change from baseline time in SBP and DBP by ambulatory blood pressure monitoring (ABPM) Timepoints:6 weeks ; Outcome name:AEs, laboratory safety tests, ECGs and vital signs. Measure:comparison of safety variables Timepoints:During the study | — |
Countries
Chile, Mexico, Peru, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed