JPRN-jRCT1080222411未知Unknown
A study to explore the effects of Azilsartan compared to Telmisartan on insulin resistance of patients with essential hypertension on type 2 diabetes mellitus by HOMA-R (AT-HOMA)
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 40 人开始时间: 2014年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- Unknown
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
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. The participant was given the diagnosis of grade I or II essential hypertension and was judged by the principal investigator or investigator that they can be appropriately treated with azilsartan 20 mg and telmisartan 40 mg.
- •2. Sitting systolic blood pressure of >= 130 mmHg and < 180 mmHg or sitting diastolic blood pressure* of >= 80 mmHg and < 110 mmHg at the start of the treatment period (Week 0)
- •* Sitting blood pressure will be measured until 2 consecutive stable measurements are obtained (i.e., the difference between 2 measurements: diastolic blood pressure of < 5 mmHg and systolic blood pressure of < 10 mmHg) after resting in a sitting position for at least 5 minutes. The average value of the last 2 measurements will be recorded (the first the decimal place is rounded off).
- •3. Type 2 diabetes mellitus
- •4. HbA1c (NGSP value) of < 8.4% during 3 months before informed consent, with a <= 0.3% change in HbA1c (peak minus nadir) during 3 months before informed consent
- •5. No change in diet/exercise therapy during the 3 months before the informed consent in a participant who has been on diet/exercise therapy and instructed to improve life style (e.g., diet and exercise)
- •6. Age >= 20 years at the time of consent
- •7. Outpatients
- •8. Capable of providing written consent before participation in this study.
排除标准
- •1. Grade III essential hypertension (i.e., sitting systolic blood pressure 180 mmHg or sitting diastolic blood pressure >= 110 mmHg), secondary hypertension, or malignant hypertension.
- •2. Grade II essential hypertension (i.e., sitting systolic blood pressure >= 160 mmHg or sitting diastolic blood pressure >= 100 mmHg) for which antihypertensive drug(s) are used
- •3. Use of oral antihypertensive medication within 2 weeks before the start of the treatment period
- •Participants who are on any antihypertensive agent at the time of informed consent can be enrolled in the study only after 2-week washout following informed consent.
- •4. Use of RAS inhibitors or thiazolidines within 3 months before the start of the treatment period
- •5. Type 1 diabetes mellitus
- •6. Fasting blood glucose of < 180 mg/dL and HOMA-R of <= 1.6 at the start of the treatment period (Week 0)
- •7. Receiving or requiring any of the following at the time of informed consent:
- •- Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, or other parenteral hypoglycemic agents
- •- Combination therapy with 3 or more oral hypoglycemic agents
- •8. Change of antidiabetic medication (including dosage change) within 3 months before the start of the treatment period
- •9. Having diagnosed/treated any of the following cardiovascular diseases within 3 months before the start of the treatment period:
- •- Cardiac disease/condition: myocardial infarction, coronary revascularization procedure
- •- Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack
- •- Advanced hypertensive retinopathy (retinal bleeding or oozing, papilloedema)
- •10. Having diagnosed/treated any of the following cardiovascular diseases more than 3 months before the start of the treatment period, and is now still in unstable condition.
- •- Cardiac disease/condition: myocardial infarction, coronary revascularization procedure
- •- Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack
- •11. Past or current history of any of the following cardiovascular diseases.
- •- Cardiac valve stenosis
- •- Angina pectoris requiring medication
- •- Congestive cardiac failure requiring medication
- •- Arrhythmia requiring medication (e.g., paroxysmal atrial fibrillation, severe bradycardia, torsade de pointes, and ventricular fibrillation)
- •- Arteriosclerosis obliterans with intermittent claudication or other symptoms
- •12. Have severe ketosis, diabetic coma or precoma, severe infection, or serious trauma
- •13. Clinically evident renal disorder (e.g., eGFR <30 mL/min/1.73 m2)
- •14. Markedly low bile secretion or severe hepatic disorder
- •15. History of hypersensitivity or allergy to azilsartan or telmisartan or to both.
- •16. Presence of hyperkalemia (potassium level >= 5.5 mEq/L on laboratory testing)
- •17. Currently participating in any other clinical study.
- •18. Pregnant women, women with possible pregnancy, or breast-feeding women.
- •19. Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.
研究者
相似试验
未知
Unknown
ALIVE studyEssential hypertensive patients with stable angina and dyslipidemiaJPRN-jRCT1080222782TAKEDA PHARMACEUTICAL COMPANY LTD.51
招募中
不适用
Evaluation for Efficacy and Safety of Azilsartan in Patients with HypertensioEssential HypertensionJPRN-UMIN000008577Department of Medicine and Bioregulatory SciencesThe University of Tokushima, Graduate School of Health Biosciences30
已完成
4 期
A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-REssential Hypertension Complicated by Type 2 Diabetes MellitusNCT02079805Takeda33
已完成
不适用
Efficacy and safety of treatment with Azilsartan in type 2 diabetes mellitus patients with hypertension who did not show target blood pressure by telmisartan.Type 2 diabetes mellitus with hypertensionJPRN-UMIN000010604Iwasaki Naika Clinic20
撤回
4 期
A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.Essential Hypertension With Stable Angina and DyslipidemiaNCT02400775Takeda