Tokyo, March 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060874) titled 'Efficacy and Safety of Sacubitril/Valsartan in Hypertensive Patients' on March 9.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Hypertension
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will examine the efficacy and safety of sacubitril/valsartan in comparison with renin-angiotensin-aldosterone system inhibitors in Japanese hypertensive patients.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - All patients were switched from renin-angiotensin system inhibitor (angiotensin-converting enzyme inhibitor or angiotensin receptor II blocker) to sacubitril/valsartan. Patients were initially instructed to take sacubitril/valsartan 100 mg once daily, and dosage was gradually increased up to 200 mg once daily and continued for 24 weeks.
Eligibility:
Age-lower limit - 18
years-old
<
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Hypertension
2) Switched from renin-angiotensin inhibitors to sacubitril/valsartan
3) Home blood pressure levels before switching did not achieve the target levels
4) Recording home blood pressure monitoring
Key exclusion criteria - 1) Received sacubitril/valsartan less than six months.
2) Non-sinus rhythm
3) Secondary hypertension
4) Myocardial infarction and/or stroke less than 30 days
5) Receiving regular hemodialysis therapy
Target Size - 50
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2022 Year 01 Month 04 Day
Date of IRB - 2025 Year 10 Month 22 Day
Anticipated trial start date - 2022 Year 01 Month 04 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065227
Disclaimer: Curated by HT Syndication.