on-inferiority trial of Anti-hypertnsive Effect of Sacubitril-Valsartan to Azilsartan In Pateints With Type 2 Daibetes Mellitus Treated With Semaglutide
Not Applicable
Recruiting
- Conditions
- hypertension, type2 daibetes mellitus
- Registration Number
- JPRN-UMIN000048598
- Lead Sponsor
- Kimitsu Chuo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with HbA1c (NGSP) less than 6.5% or greater than 10% at the start of the study (2) Patients with systolic blood pressure less than 140 mmHg (3) Patients who are incapable of adequate understanding or cooperation due to mental dysfunction, uncooperative participation, or language barriers (4) Patients with a history of hypersensitivity to Azilsartan, valsartan, or sacubitril valsartan (5) Pregnant women or patients who may be or are planning to become pregnant (6) Patients using Aliskiren-fumarate (7) Patients with a history of angioedema (8) Patients with bilateral renal artery stenosis (9) Patients with severe hepatic impairment (Child-Pugh classification C)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Systolic blood pressure variation in two groups at 24 weeks after test drug administration.
- Secondary Outcome Measures
Name Time Method Heart rate, blood test(AST, ALT, BUN, Creatinin, NT-proBNP, eGFR, renin/aldosteron ratio), urine albumin, fast blood glucose, HbA1c, insulin, C-peptide release, Inbody-analysis, hypotension, hypoglycemic symptoms, drug rash at12and 24weeks after drug administration.