None listed
Conditions
Interventions
Placebo once a day (QD) for 6 months
Group 1 Type of group
TAK-491 20, 40 and 80 mg QD for 6 months
Group name:Group 3 Type of group
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient has essential hypertension (defined as a valley value of clinical SBP, in the sitting position, between 150 and 180 mmHg, including Day -1 [day before randomization] and mean SBP of 24 hours> 130 mmHg on Day 1). • Man or woman 16 years of age or older • A woman of childbearing age (ie, not sterile and premenopausal), sexually active, who agrees to use an adequate contraceptive method (as defined in the informed consent form) from the selection to the end of the study. • The patient has laboratory clinical analyzes (including chemical analysis, hematology and complete urinalysis) within the reference values ​​corresponding to the laboratory or with results that the investigator considers are not clinically significant to affect the inclusion of the patient in this study. • Patient is willing to discontinue current antihypertensive medications on Day -21 of the selection. If the patient is receiving amlodipine before the Screening, he or she should be willing to stop this medication on Day -28 of the selection.
Exclusion criteria
Exclusion criteria: • The patient has a valley value of clinical PAD, in a sitting position, greater than 114 mmHg on Day -1 (day before the randomization). • The patient underwent a 24-hour reference MAP with insufficient quality readings (as described in the protocol). • The patient takes or should take an excluded medication, as described in the excluded medications section. • The patient is hypersensitive to angiotensin II receptor blockers (ARBs). • The patient has a history 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 defects (eg, third-degree atrioventricular block [AV], left bundle branch block, sick sinus syndrome, atrial fibrillation, or atrial flutter). • The patient has a hemodynamically significant left ventricular outflow tract obstruction due to an aortic valvular disease. • The patient has secondary hypertension of diverse etiology (for example, renovascular disease, pheochromocytoma, Cushing´s syndrome). • The patient does not comply with the regimen of the study medication ( 130%) during the placebo start period. • The patient has severe kidney disease or dysfunction (based on calculated creatinine clearance 9.5%) at the time of selection. • The patient has a level of alanine aminotransferase (ALT) 2.5 times higher than the upper limit of normal, active liver disease or jaundice at the time of selection. • The patient has hyperkalemia (blood potassium levels above the upper limit of normal, according to the central laboratory) at the time of selection. • The circumference of the patient´s arm is less than 24 cm or more than 42 cm. • The patient works at night (third tumor, from 11 p.m. [23:00] to 7 a.m. [07:00]). • patient can not or is not willing to comply with the protocol or scheduled consultations. • The patient is unable to understand the oral or written English or another language to which a certified translation of the approved informed consent has been made. • Woman who is pregnant, who plans to become pregnant during the course of the study or who is breastfeeding. • The patient is currently participating in another research study or has participated in a research study within 30 days prior to the selection. • The patient is an employee of the center or is a direct relative (that is, spouse, father, mother, son or sister) of an employee of the center who works in the development of this study. • The patient has some other disease or serious condition at the time of selection (or r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:measured by MAP with respect to the reference value. Measure:Change produced in the average PAS values of 24 hours Timepoints:24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:measured by MAP with with respect to the reference value. Measure:Change produced in the values of the average PAD of 24 hours Timepoints:24 hours ; Outcome name:In the sitting position with respect to the reference value. Measure:Change in the valley values of SBP and PAD clinics Timepoints:24 hours ; Outcome name:They include a daily average [6 a.m. to 10 p.m.], midnight [12 a.m. at 6 a.m.], mean arterial pressure from 0 to 12 hours after dose administration, average valley values between 22 to 24 hours after dose administration, peak effect and valley-peak relationship Measure:PAS and PAD using additional MAP parameters Timepoints:24 hours ; Outcome name:The endpoints are HA. safety laboratory analysis, ECG determinations and vital signs. Measure:Safety Timepoints:When the event happens | — |
Countries
Argentina, Mexico, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed