NCT01602367终止2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2B Trial to Evaluate the Safety and Efficacy of BMS-823778 in Overweight and Obese Subjects With Inadequately Controlled Hypertension
Bristol-Myers Squibb14 个研究点 分布在 2 个国家目标入组 7 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 14
- 主要终点
- The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment
研究概览
简要总结
The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic
- •Mean 24-hour diastolic blood pressure ≥85 mmHg
- •Body mass index (BMI) ≥27 kg/m2
- •If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks
排除标准
- •History of Cushing's disease or syndrome, or Addison's disease
- •Glycosylated hemoglobin (HbA1c) ≥10%
- •Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months
- •History of impaired renal or hepatic function
- •BMI ≥50 kg/m2
- •Any injectable antihyperglycemic agent (such as insulin) within 16 weeks
- •Currently receiving more than one class of antihypertensive agents within 4 weeks
- •Daily use of nonsteroidal anti-inflammatory agents within 1 week
- •Use of androgen medications, including topical preparations, within 6 weeks
- •Diagnosis or history of breast cancer
研究组 & 干预措施
Arm 1: BMS-823778 (2mg)
Experimental
干预措施: BMS-823778 (Drug)
Arm2: BMS-823778 (6mg)
Experimental
干预措施: BMS-823778 (Drug)
Arm 3: BMS-823778 (15mg)
Experimental
干预措施: BMS-823778 (Drug)
Arm4: Placebo
Experimental
干预措施: Placebo matching with BMS-823778 (Drug)
结局指标
主要结局
The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment
时间窗: At Day -7 (baseline) and Week 12
次要结局
- Change in 24-hour ambulatory SBP(At Day -7 (baseline) and Week 12)
- Change in seated SBP(At Day -7 (baseline) and Week 12)
- Change in seated DBP(At Day -7 (baseline) and Week 12)
- Change in 24-hour ambulatory diastolic blood pressure (DBP)(At Day -7 (baseline) and Week 12)
- Change in ambulatory daytime and nighttime SBP(At Day -7 (baseline) and Week 12)
- Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)(At Day -7 (baseline) and Week 12)
- Change in ambulatory daytime and nighttime DBP(At Day -7 (baseline) and Week 12)
研究者
研究点 (14)
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