An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin Tablets, 20 mg, for the Management of Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 673
- 试验地点
- 2
- 主要终点
- Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12
研究概览
简要总结
This integrated assessment consists of two studies, 603A and 603B, to be carried out sequentially in a common study population. Participating subjects informed of the trial design and their consent to participate in both studies were to be obtained in a single consent form. Approximately 680 male or female adult subjects were to be enrolled.
详细描述
THR-1442-C-603 is an integrated assessment of the potential utility of bexagliflozin tablets, 20 mg for the treatment of essential hypertension. It is composed of two studies, 603A and 603B, measuring effects in a common population.
603A was a multicenter double-blind parallel group placebo-controlled study conducted to determine the placebo-adjusted change from baseline to week 12 in the mean ambulatory systolic blood pressure (SBP) of approximately 680 subjects considered generally representative of the adult hypertensive population in the United States. Secondary endpoints included the placebo-adjusted change from baseline to week 12 of the mean office seated systolic blood pressure, the change to week 12 of the mean ambulatory and mean office seated diastolic blood pressure, the proportion of subjects achieving prespecified goals for absolute systolic and diastolic blood pressure as well as prespecified goals for reduction in systolic and diastolic blood pressure, measured by ambulatory and seated office measurement methodology.
A603B was a multicenter double-blind parallel group placebo-controlled randomized withdrawal study conducted to determine the durability of the antihypertensive effect of bexagliflozin tablets, 20 mg, in a population not pre-selected for existing diabetes. All subjects entered a 12 week run-in period during which they self-administered open label bexagliflozin tablets, 20 mg once daily. At week 12 a baseline ambulatory blood pressure monitoring (ABPM) measurement was made, and the subjects were randomized one to one to receive either bexagliflozin tablets, 20 mg or bexagliflozin tablets, placebo. After a 12 week treatment period a second ABPM measurement was made. The primary endpoint was the intergroup difference in the change from baseline in the mean SBP.
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)
盲法说明
- Study 603A: bexagliflozin tablets, 20 mg or placebo
- Study 603B week 1 to week 12: bexagliflozin tablets, 20 mg, open-labeled
- Study 603B week 13 to week 24: bexagliflozin tablets, 20 mg or placebo
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence 4
Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Placebo
干预措施: Bexagliflozin (Drug)
Sequence 1
Period 1: Placebo Period 2: Bexagliflozin Period 3: Bexagliflozin
干预措施: Bexagliflozin (Drug)
Sequence 1
Period 1: Placebo Period 2: Bexagliflozin Period 3: Bexagliflozin
干预措施: Placebo (Drug)
Sequence 2
Period 1: Placebo Period 2: Bexagliflozin Period 3: Placebo
干预措施: Bexagliflozin (Drug)
Sequence 2
Period 1: Placebo Period 2: Bexagliflozin Period 3: Placebo
干预措施: Placebo (Drug)
Sequence 3
Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Bexagliflozin
干预措施: Bexagliflozin (Drug)
Sequence 4
Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12
时间窗: Baseline (Day 1) to week 12
Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared to placebo
Change of the 24 Hour Mean Systolic Blood Pressure From Cumulative Week 24 to Week 36
时间窗: Change from week 24 to week 36
Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared placebo
次要结局
- 603A, Change in Seated Office Systolic Blood Pressure(Baseline (Day 1) to week 12)
- 603A, Seated Office Systolic Blood Pressure of 140 mm Hg or Less(Baseline (Day 1) to week 12)
- 603A, Seated Office Diastolic Blood Pressure of 90 mm Hg or Less(Baseline (Day 1) to week 12)
- 603A, Change in Mean Ambulatory Diastolic Blood Pressure(Baseline (Day 1) to week 12)
- 603B, Change in Seated Office Systolic Blood Pressure(Week 12 (cumulative week 24) to Week 24 (cumulative week 36))
- 603B, Change in Seated Office Diastolic Blood Pressure(Week 12 (cumulative week 24) to Week 24 (cumulative week 36))
- 603A, Reduction of Mean Ambulatory Systolic Blood Pressure(Baseline (Day 1) to week 12)
- 603A, Mean Ambulatory Diastolic Blood Pressure of 87 mm Hg or Less(Baseline (Day 1) to week 12)
- 603A, Mean Ambulatory Systolic Blood Pressure of 135 mm Hg or Less(Baseline (Day 1) to week 12)
- 603A, Change in Seated Office Diastolic Blood Pressure(Baseline (Day 1) to week 12)
- 603B, Change in Mean Ambulatory Diastolic Blood Pressure(Week 12 (cumulative week 24) to Week 24 (cumulative week 36))
- 603A, Reduction of Mean Ambulatory Diastolic Blood Pressure of 4 mm Hg or Greater(Baseline (Day 1) to week 12)