EUCTR2010-019155-22-GB进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Parallel-Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with Essential Hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 596
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female aged = 18 years
- •2. Subjects with history of mild to moderate essential hypertension for at least 2 months and with mean sitting SBP = 140 mmHg and = 179 mmHg; and mean sitting DBP = 90 mmHg and = 109 mmHg at screening (V1) and at baseline (V2)
- •3. Written informed consent to participate in the study before starting any study-specific procedures at V1 (screening)
- •4. Compliance with the study medication > 80% and < 120% during the 3-week placebo washout period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 358
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 238
排除标准
- •1. Women of childbearing potential without hormonal, barrier or intrauterine contraception methods
- •2. Inability to discontinue all prior antihypertensive medications safely for the duration of the washout period, subjects on triple combination of antihypertensive drugs at V1 or subjects on dual combination with moderate hypertension (SBP=160-179 mmHg and/or DBP =100-109 mmHg) at V1
- •3. Pregnant or breast-feeding female subject
- •4. Any secondary form of hypertension
- •5. Severe (Grade 3) hypertension (SBP = 180 mmHg and/or DBP = 110 mmHg)
- •6. Presence of the differences greater than 20mmHg for SBP and 10mmHg for DPB on 3 consecutive readings at V1 or V2
- •7. Angina pectoris that is currently being treated with long acting nitrates, beta-blockers, or calcium channel blockers unless kept on stable doses for the duration of the study
- •8. Severe diabetes mellitus (HbA1c greater 8.5%) with metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration)
- •9. Nonresponders to ACE inhibitors or angiotensin receptor blockers (ARBs), however, subjects known to be intolerant to ACE inhibitors are allowed except for a low-dose aspirin (75-325mg
- •10. Concomitant administration of lithium and NSAIDs except for a low-dose aspirin (75-325mg per day)
- •11. New York Heart Association (NYHA) Class IV congestive heart failure
- •12. Myocardial infarction or unstable angina within the preceding 90 days
- •13. Aortic and mitral valve stenosis, hypertrophic cardiomyopathy
- •14. Known or suspected hemo-dynamically significant bilateral renal artery stenosis or severe stenosis of a solitary functioning kidney
- •15. Severe renal impairment (creatinine clearance < 30 mL/min)
- •16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2 times the upper limit of normal and/or total bilirubin > 3 mg/dL
- •17. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •18. Active alcohol or drug abuse
- •19. Known hypersensitivity to the active substances of eprosartan or to any of its excipients, or to sulfonamide derived substances (such as HCTZ)
- •20. Administration of an investigational drug or device, or participation in an investigational trial within 30 days
- •21. Clinically significant laboratory abnormalities or medical conditions which, in the opinion of the Investigator, make them unsuitable for evaluation
- •22. Subjects withdrawn from the study cannot re-enter this trial
研究者
相似试验
已完成
不适用
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillatio-I48 Atrial fibrillation and flutterAtrial fibrillation and flutterI48PER-025-07BAYER S.A.,
已完成
3 期
A study comparing the efficacy and safety of once-daily oral rivaroxaban with warfarin for the prevention of stroke and embolism in patients with atrial fibrillation.on-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation.Non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation.Stroke - IschaemicStrokeACTRN12607000214437Bayer Australia Limited14,269
进行中（未招募）
不适用
A Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with High Blood PresureEUCTR2010-019155-22-DEAbbott Healthcare Products B.V.665
招募中
4 期
To Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Healthy Children.CTRI/2022/05/042364OmniActive Health Technologies Ltd
已完成
3 期
To understand the safety and effects of Ashwagandha in healthy adults with stressCTRI/2024/03/063786OmniActive Health Technologies Limited90