Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061780) titled 'A trial to evaluate the efficacy and safety of Sacubitril/valsartan treatment in patients with difficult-to-control hypertension' on June 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Yokohama Sakae Kyosai Hospital
Condition:
Condition - Patients with essential hypertension who have poor blood pressure control despite combination therapy with ARBs and CCBs
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy and safety of adding Sacubitril/Valsartan to the regimen in patients with uncontrolled hypertension despite combination therapy with angiotensin II receptor blockers (ARBs) and calcium channel blockers (CCBs), compared with adding a diuretic.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Sacubitril/Valsartan Group
Interventions/Control_2 - Indapamido Group
Eligibility:
Age-lower limit - 18
years-old
=180 mmHg or diastolic blood pressure >=110 mmHg).
4. Patients with clearly secondary hypertension due to underlying conditions such as primary aldosteronism, renovascular hypertension, or pheochromocytoma
5. Patients requiring renal replacement therapy or with severe renal impairment (eGFR3.5 g/gCr)
7. Severe hepatic impairment (e.g., cirrhosis, Child-Pugh Class C),
8.NYHA Class III or higher, poorly controlled severe chronic heart failure
9. End-stage malignant disease
10. Patients with severe infections
11. Pregnancy
12. Patients deemed unsuitable for enrollment by the attending physician due to poor adherence to medical visits or medication
Target Size - 140
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 30 Day
Date of IRB - 2026 Year 03 Month 16 Day
Anticipated trial start date - 2026 Year 06 Month 03 Day
Last follow-up date - 2027 Year 12 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070696
Disclaimer: Curated by HT Syndication.
