None listed
Conditions
Interventions
Group 1 Type of group
TAK-491 placebo + chlorthalidone 25 mg QD orally for 8 weeks
Group name:Group 3 Type of group
TAK-491 80 mg + chlorthalidone 25 mg QD orally for 8 weeks
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 arterial hypertension (defined as a nadir PAS measured in the clinic in a sitting position between 160 and 190 mm Hg inclusive at Day -1 [day before randomization]) and an average SBP of 24 hours> 140 mm Hg and <180 mm Hg to Day 1. • The patient is male or female and is 18 years of age or older. • 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 women patients of childbearing age should agree to use an adequate contraceptive method (as indicated on the informed consent form) from the selection period and throughout the study. • The patient presents clinical laboratory evaluations (including clinical biochemistry, hematology, and complete urine analysis) within the reference range for laboratory tests or with results considered clinically insignificant at the discretion of the investigator, to be included in 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 be willing to discontinue this treatment in the Day -28 Selection.
Exclusion criteria
Exclusion criteria: • The patient has a diastolic blood pressure (DBP) nadir measured in the clinic in a sitting position> 119 mm Hg to Day -1 (day prior to randomization). • The patient has a baseline 24-hour MAP reading of insufficient quality (as defined in the protocol). • The patient is receiving or expects to receive an excluded medication (see the Excluded Medications Section). • The patient has hypersensitivity to AIl receptor blockers, to thiazide-type diuretics, or to other compounds derived from sulfonamide. • 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 disturbances (eg, 3rd-degree atrioventricular block [AV], left bundle branch block [LBB], sick sinus syndrome, atrial fibrillation). • The patient presents hemodynamically significant left ventricular outflow obstruction 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 treatment with the study drugs (compliance less than 70% or greater than 130%) during the period of preparation with placebo. • The patient has a renal dysfunction or severe kidney disease (based on a calculated creatinine clearance 8.0%). • The patient has hypo- or hyperkalemia (defined as a serum potassium outside the normal reference range of the central laboratory). • The patient has a concentration of alanine aminotransferase (ALT) greater than 2.5 times the normal upper limit value, active liver disease, or jaundice. • The patient has a circumference of the upper arm less than 24 cm or greater than 42 cm. • The patient works on a rotating night schedule (defined as from 11 PM [23:00 hours] until 7 AM [7:00 AM]). • 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. • 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 is an employee of the research center, or is an immediate family member (eg, spouse, parent, child, sibling) of an employee of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:obtained by ambulatory blood pressure monitoring (ABPM). Measure:Change with respect to the baseline in the average 24-hour SBP Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:obtained by ambulatory blood pressure monitoring (ABPM), with TAK-491. Measure:The change from the baseline in the mean 24-hour DBP Timepoints:6 weeks ; Outcome name:measured in the clinic in sitting, with TAK-491. Measure:The change with respect to the baseline in. the PAS and PAD nadir measured in the clinic in sitting, with TAK-491. Timepoints:6 weeks ; Outcome name:Using the additional ABPM parameters (mean daytime value [6 AM to 10 PM], mean nighttime value [12 AM to 6 AM], mean PA from O to 12 hours later of the dose, average value in the valley from 22 to 24 hours after the dose). Measure:The change with respect to the baseline in systolic and diastolic blood pressure Timepoints:6 weeks ; Outcome name:EAs, safety laboratory tests, ECG and vital signs. Measure:Safety assessment criteria Timepoints:During the study | — |
Countries
Peru, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed