None listed
Conditions
Interventions
GROUP 1 Type of group
This group will discontinue their usual antihypertensive medication and start treatment with TAK-191 Placebo PO QD for 3 weeks. After this the placebo will be replaced by Olmesartan 20 mg PO QD for 8 weeks.
Group name:GROUP 7 Type of group
This group will discontinue their usual antihypertensive medication and start treatment with TAK-191 Placebo PO QD for 3 weeks. After this TAK-191 Placebo PO QD will continue for 8 more weeks.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is male or female, 18 years of age or older, with mild to moderate uncomplicated essential hypertension. 2. The subject is able to understand and comply with the requirements of the protocol. 3. The subject or their legal representative signs an informed consent form before initiating any study procedure. 4. Women likely to become pregnant should not be pregnant or breast-feeding: they should also have a negative pregnancy test result with human chorionic gonadotropin (HCG) before receiving any dose of study medication. In addition, patients will use acceptable contraceptive methods. 5. The subject must enjoy good health. 6. The subject has clinical laboratory evaluations within the reference range. 7. The subject is willing to suspend the use of the current antihypertensive medication on day -21 of the selection stage.
Exclusion criteria
Exclusion criteria: 1. The subject has a DBP less than 95 or greater than 114 mmHg on day -14 of pre-inclusion with placebo or at the randomization visit or has a SBP greater than 180 mmHg. 2. Subject has a reduction greater than or equal to 8 mmHg in clinical PAD between day -14 of pre-inclusion with placebo and the randomization visit. 3. In the 7 days prior to the placebo pre-inclusion period, the subject has taken, or is expected to take, medications that affect blood pressure. 4. The subject is hypersensitive to AII receptor blockers. 5. Subject has a history of acute MI within 12 months prior to Screening, history of coronary revascularization within 6 months prior to Screening, or any history of heart failure, post-MI, hypertensive encephalopathy, stroke or transient ischemic attack (TIA). 6. Subject has clinically significant cardiac conduction defects 7. The subject has secondary hypertension of any etiology. 8. The subject has a circumference less than 24 cm or greater than 42 cm in the upper arm. 9. The subject works in the night shift (3rd shift). 10. The subject does not comply with the study medication during the period of pre-inclusion with placebo. 11. The subject has moderate to severe significant renal dysfunction or kidney disease. 12. The subject has a history of drug abuse or a history of alcohol abuse in the last 2 years. 13. The subject has a history of cancer that is not in remission for at least 5 years before the first dose of the study drug. 14. The subject has diabetes mellitus type 1 or type 2 uncontrolled. 15. The subject has a level of alanine aminotransferase (ALT) in more than 2.5 times the upper limit of the normal range, active liver disease or jaundice. 16. The subject does not show willingness or can not comply with the protocol or scheduled appointments. 17. The subject is unable to understand spoken or written English, or any other language in which a certified translation of the approved informed consent is available. 18. The patient is pregnant, plans to become pregnant during the study or is breastfeeding. 19. The subject is currently participating in another research study or has participated in a research study within 30 days prior to randomization. 20. The subject suffers from any other disease or serious condition during the Screening that would jeopardize the safety of the same, could affect the life expectancy, or hinder the management and successful follow-up of the subject according to the protocol. 21. The subject is an employee of the center or is a member of the immediate family of a center employee, involved in the conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: PA in sitting position in the office (after 5 minutes of sitting). The subjects must be evaluated by the same researcher or center staff, with the same equipment and using the same arm (non-dominant) for serial BP measurements (three sitting and one standing). A mercurial sphygmomanometer (preferably) or a certified calibrated automated tensiometer with the appropriate sleeve size should be used. Measure:Clinical diastolic blood pressure (BP) in the sitting position. Timepoints:Final visit: Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical BP measurements should be taken approximately 24 hours after the previous dose and before dosing or blood collection on the day of double-blind treatment visits. A mercurial sphygmomanometer (preferably) or a certified calibrated automated tensiometer with the appropriate sleeve size should be used. The PA will be measured in the sitting position in the office (after 5 minutes of sitting), PA in the standing position in the office (after 2 minutes of standing). The subjects must be evaluated by the same researcher or center staff, with the same equipment and using the same arm (non-dominant) for serial BP measurements (three sitting and one standing). Ambulatory Blood Pressure Monitoring (ABPM): It will include the 24-hour, half-day median, based on measurements at 6 AM and 10 PM and minimum mean based on measurements 22 to 24 hours (after dosing). Measure:1) Systolic blood pressure in sitting position (clinical). 2) Standing systolic blood pressure (clinical). 3) Systolic and diastolic blood pressure using MAP measurements Timepoints:Final visit: Week 8. ; Outcome name:Clinical evaluation of adverse events, defined as any unwanted medical situation in a research subject receiving a pharmaceutical product. It is not necessary that the event has a causal relationship with this treatment. Safety tests in the laboratory: Hematology and serum biochemistry panels, urinalysis. ECG: A standard 12-lead ECG will be done. A qualified physician will interpret the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant. Vital Signs: Blood pressure and pulse. Measure:Safety of treatment: Adverse events. Safety tests in the laboratory. Electrocardiograms (ECGs). Vital signs. Timepoints:Adverse events: Days -14, - 7 and 1 and weeks 1, 2, 4, 6 and 8. Laboratory safety tests: Days -12, - 14 and 1, and weeks 4 and 8. ECG: The da | — |
Countries
Argentina, Chile, Mexico, Peru, United States
Outcome results
None listed