CTRI/2011/09/001983尚未招募3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects WithType 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 765
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
入选标准
- •Males and females, 18 to 65 years old, with type 2 diabetes with inadequate
- •glycemic control HbA1c between 7-10% and uncontrolled hypertension SBP 140-165 and DBP 85-105. Upper Limit of age of 65 years is in accordance with conditions set by Drug Controller General (India) for subjects participating from Indian sites.
- •Subjects must have a mean 24 hr blood pressure more than or equal to 130/80 determined by ABPM within 1 week prior to Day 1 visit.
- •Stable dose of oral antidiabetic agent (OAD) for 6 weeks (12 wks for TZD) and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for 4 weeks
- •C-peptide more than or equal to .08 ng/mL
- •Body Mass Index less than or equal to 45.0 kg/m2
- •Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women
排除标准
- •AST and /or ALT 3.0 times the upper limit of normal (ULN)
- •Serum total bilirubin more than 1.5 X ULN
- •Creatinine kinase more than 3 X ULN
- •Symptoms of severely uncontrolled diabetes
- •History of malignant or accelerated hypertension
- •Currently unstable or serious cardiovascular, renal, hepatic, hematological,oncological, endocrine, psychiatric, or rheumatic diseases
研究者
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