jRCT2031250164尚未招募不适用
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION) (J2A-MC-GZPL )
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 974
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Screening
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has systolic blood pressure (SBP) >= 140 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg (if DBP criteria alone is met, SBP must be >=130 mmHg) at screening (Visit 1).
- •Has SBP >= 140 mmHg and/or DBP >= 90 mmHg (if DBP criteria alone is met, SBP must be >=130 mmHg) at week 0 (Visit 3).
- •Untreated for hypertension, or on stable antihypertensive medications >= 30 days prior to Visit
- •Have a body mass index (BMI) >= 25 kg/m2.
排除标准
- •Has SBP >=170 mmHg and/or DBP >=110 mmHg at Visit 1 or at Visit
- •Has known secondary causes of hypertension
- •Have heart failure with reduced ejection fraction (HFrEF) diagnosis
- •Have had any of the following conditions within 90 days prior to screening.
- •hospitalization for hypertension or for congestive heart failure
- •acute coronary syndrome or acute myocardial infarction, or
- •cerebrovascular accident (stroke).
- •Have type 1 diabetes (T1D)
- •Have acute or chronic hepatitis, including a history of autoimmune hepatitis
结局指标
主要结局
-
Number of Participants Allocated to Each ISA [ Time Frame: Week -8 to Week 0
次要结局
未报告次要终点
研究者
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