JPRN-jRCTs031200273已完成未知
Clinical Study to Assess the Efficacy and Safety of Esaxerenone in Patients with Type 2 Diabetes Mellitus and Hypertension using Sodium Glucose Co-transporter 2 Inhibitor
Motoki Hirohiko0 个研究点目标入组 93 人开始时间: 2020年12月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 93
研究概览
简要总结
In hypertensive patients with diabetes taking SGLT2 inhibitor with inadequate response to basal antihypertensive drug(s), esaxerenone significantly reduced BP and UACR, confirming the antihypertensive and renoprotective effects of esaxerenone. In the study, there was no serious adverse drug reaction, and no safety issue.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients aged 20 years or older
- •2) Patients with type 2 diabetes
- •3) Patients treated oral hypoglycemic drugs (one SGLT2 inhibitor, one SGLT2 inhibitor + one other oral hypoglycemic drug combination, or one SGLT2 inhibitor + two other oral hypoglycemic drug combination) at a fixed dosage
- •4) Patients treated basal antihypertensive drugs (one RAS inhibitor, one Ca channel blocker, or one RAS inhibitor + one Ca channel blocker)
- •5) Patients with hypertension (early morning home blood pressure [BP]: =>125 mmHg and <160 mmHg of systolic blood pressure and/or =>75 mmHg and <100 mmHg of diastolic blood pressure)
- •6) Patients whose eGFRcreat (mL/min/1.73 m2) is 30 or more
- •7) Patients who can measure home blood pressure
排除标准
- •1) Patients diagnosed with secondary hypertension or patients with malignant hypertension
- •2) Patients treated insulin and GLP-1 receptor agonist
- •3) Patients with nephrotic syndrome
- •4) Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L
- •5) Patients with any cerebro-cardiovascular diseases
- •6) Patients had NYHA class IV
- •7) Patients treated contraindication medicine specified in this study within 4 weeks prior to enrollment
- •8) Patients with severe liver dysfunction (liver failure, cirrhosis, etc.)
- •9) Patients diagnosed with life expectancy within one year due to some disease
- •10) Patients with a history of serious drug allergy
- •11) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
- •12) Patients who are inappropriate for this study judged by their primary physicians
研究者
相似试验
已完成
4 期
useogliflozin ABPM studyType 2 diabetes mellitusJPRN-jRCTs011180019Cho Kyuyong68
招募中
不适用
SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry StudyMyocardial InfarctionDiabetes Mellitus, Type 2NCT05770687Kiyuk Chang1,000
招募中
不适用
The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.Diabete MellitusCoronary Artery DiseaseNCT05333159Beijing Anzhen Hospital1,424
招募中
不适用
Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease.Type 2 diabetes complicated by non-alcoholic fatty liver diseaseJPRN-UMIN000018166Toranomon Hospital, Department of Hepatology15
已完成
3 期
An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)Chronic Renal InsufficiencyDiabetes Mellitus, Type 2NCT00095056Merck Sharp & Dohme LLC91