None listed
Conditions
Interventions
Group 1 Type of group
TAK-491 placebo + amlodipine 5 mg QD orally for 8 weeks
Group name:Group 3 Type of group
TAK-491 80 mg + amlodipine 5 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 PAS nadir measured in the clinic in a sitting position between 160 and 190 mm Hg including Day -1 [day prior to randomization]) and an average SBP of 24 hours> 140 mm Hg and <180 mm Hg on Day 1 (day of randomization). • The patient is male or female 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. • Female patients of childbearing age and sexually active 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 urinalysis) within, reference range for laboratory tests considered by the investigator as not clinically significant for inclusion within the study. • The patient is willing to suspend their current antihypertensive medications at the Day-21 screening visit. 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 diastolic blood pressure (DBP) nadir measured in the clinic in a sitting position> 119mmHg at Day -1 (the day before the 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 a medication that is excluded, as indicated in the Excluded Medications section. • The patient has hypersensitivity to AII receptor blockers or calcium channel blockers. • The patient has a recent history (within 6 months) myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy, stroke, or ischemic stroke transient (AIT) • The patient has clinically significant cardiac conduction abnormalities (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 has secondary arterial hypertension of any etiology (for example, renovascular disease, pheochromocytoma, Cushing´s syndrome). • The patient does not comply with the treatment with the study medications (less than 70% or greater than 130%) during the period of preparation with placebo. • The patient has renal dysfunction or severe kidney disease (based on a calculated creatinine clearance 8.0%). • The patient has hyperkalemia defined by the range of normal reference values ​​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 7:00 AM [7:00 hours]) every two nights. • 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 study center, or is an immediate family member (eg spouse, parent, child, sibling) of an employee of the study center who is involved in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:obtained by ambulatory blood pressure monitoring (ABPM). Measure:Change with respect to the baseline in the mean 24-hour SBP obtained by MAPA. Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:obtained by ambulatory blood pressure monitoring (ABPM), with TAK-491. Measure:The change with respect to the baseline in the mean 24-hour PAD obtained by MAP with TAK-491 Timepoints:6 weeks ; Outcome name:measured in the clinic in sitting, with TAK-491. Measure:The change with respect to the baseline in the SBP and DBP nadir measures in the clinic in sitting with TAK-491. Timepoints:6 weeks ; Outcome name:using the additional ABPM parameters (mean daytime [6 AM to 10 PM], nocturnal mean [12 AM to 6 AM], mean BP from 0 to 12 hours after the dose, mean in the valley of 22 to 24 hours after the dose) Measure:Systolic and diastolic blood pressure Timepoints:6 weeks ; Outcome name:EAs, safety laboratory tests, ECGs and vital signs. Measure:Safety assessment criteria Timepoints:6 weeks | — |
Countries
Peru, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed