An Exploratory, Randomized, Double-blind, Placebo-controlled, Parallel Arm Trial of the Safety and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients Hospitalized With Worsening Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths
研究概览
简要总结
Primary Objectives:
- Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo.
- Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Secondary Objectives:
- Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
- Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
详细描述
The total study duration will be approximately 27-40 days, including a screening period of 1-10 days, a treatment period of 14 days, and a follow-up period of 14±2 days.
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 —（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
Placebo
Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
干预措施: Placebo (Drug)
Sotagliflozin 200 mg
Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
干预措施: Sotagliflozin (Drug)
Sotagliflozin 200 mg
Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
干预措施: Placebo (Drug)
Sotagliflozin 400 mg
Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
干预措施: Sotagliflozin (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths
时间窗: Baseline up to Day 14
AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.
Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14
时间窗: Baseline to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14
时间窗: Baseline to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14
时间窗: Baseline to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14
时间窗: Baseline to Day 14
Changes From Baseline in Plasma Volume to Day 14
时间窗: Baseline to 14 Days
Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.
次要结局
- Change From Baseline in Erythropoietin to Day 14(Baseline to Day 14)
- Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14(Baseline to Day 14)