EUCTR2008-000874-19-NL进行中（未招募）不适用
A Phase III, eight week randomised double-blind, double-dummy,forced titration study to compare the fixed-dose combination tablet oftelmisartan 80 mg plus amlodipine 10 mg versus amlodipine 10 mgover encapsulated capsules mono-therapy as first line therapy inpatients with type 2 diabetes mellitus and Stage I or II hypertension - TEAMSTAT2DM
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- 性别
- All
入选标准
- •Baseline mean seated systolic blood pressure >150 mmHg; diagnosis of type 2 diabetes mellitus; age = >18; ability to stop current antihypertensive therapy without unacceptable risk to the patient and ability to provide written informed consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pre-menopausal women who are not pregnant, nursing, surgically sterile or practicing approved birth control; night shift workers; mean seated systolic =>180 and/or diastolic >=120 mmHg; type 1 diabetes mellitus; renal dysfunttion defined by laboratory parameters; functional class III-IV CHF; sensitivity to study drugs; concomitant medication known to affect blood pressure and unstable diabetes defined by HbA1c >10%
研究者
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