Hypertensive Subjects With Moderate Renal Impairment MedDRA version: 12.1 Level: LLT Classification code 10062237 Term: Renal impairment MedDRA version: 12.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is treated with 2 or 3 antihypertensive medications and on stable therapy, defined as =6 weeks on medication, and has a mean sitting clinic SBP =135 and =160 mm Hg at the Screening Visit and on Day 1. 2. The subject has eGFR in the range of =30 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has received any investigational compound within 30 days prior to Screening or is currently participating in another investigational study. 2. The subject has been randomized/enrolled in a previous TAK-491 or TAK-491CLD study. NOTE: This criterion does not apply to subjects who began participation in another TAK-491 or TAK-491CLD study but were not randomized/enrolled, nor does it apply to subjects who participated in observational studies that lacked an intervention or invasive procedure. 3. The subject is receiving a combination of OLM and HCTZ at the Screening Visit. 4. The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 5. The subject has a mean clinic DBP (sitting, trough) >110 mm Hg on Day 1. 6. The subject has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing’s syndrome). 7. The subject has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 8. The subject has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome). 9. The subject has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 10. The subject has severe renal dysfunction or disease (based on eGFR 2000 mg/g at Screening). 11. Subject has known or suspected unilateral or bilateral renal artery stenosis. 12. The subject has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those subjects with basal cell or stage I squamous cell carcinoma of the skin.) 13. The subject has poorly-controlled type 1 or 2 diabetes mellitus (glycosylated hemoglobin A [HbA1c] >8.5%) at Screening. 14. The subject has hypokalemia or hyperkalemia (defined as serum potassium outside of the normal reference range of the central laboratory). 15. The subject has an alanine aminotransferase or aspartate aminotransferase level of >2.5 times the ULN, active liver disease, or jaundice. 16. The subject has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol. 17. The subject has a history of hypersensitivity or allergies to ARBs or thiazide-type diuretics or other sulfonamide-derived compounds. 18. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within the past 2 years. 19. The subject is required to take excluded medications 20. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of a TAK-491 plus chlorthalidone FDC (TAK-491CLD FDC) in comparison with the OLM/HCTZ FDC in hypertensive subjects with moderate renal impairment.;Secondary Objective: The secondary objective of this study is to evaluate the long-term efficacy of TAK-491CLD FDC in comparison to OLM/HCTZ when using a titration to target treatment approach.;Primary end point(s): Percentage of subjects with at least 1 AE from Day 1 to Week 52. | — |
Countries
Bulgaria, Germany, Latvia, Lithuania, Netherlands
Outcome results
None listed