DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Aldosterone-to-renin Ratio
研究概览
简要总结
The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.
详细描述
A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a guideline-recommended diagnosis of primary aldosteronism
排除标准
- •Patients with primary aldosteronism and
- •hyperkalemia
- •prolonged QT intervals
- •refusal of special contraception measures
研究组 & 干预措施
4 mg DP13 daily
DP13 for 8 weeks
干预措施: dexfadrostat phosphate (Drug)
8 mg DP13 daily
DP13 for 8 weeks
干预措施: dexfadrostat phosphate (Drug)
12 mg DP13 daily
DP13 for 8 weeks
干预措施: dexfadrostat phosphate (Drug)
结局指标
主要结局
Change in Aldosterone-to-renin Ratio
时间窗: 8 weeks
Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.
Change in Ambulatory Systolic Blood Pressure
时间窗: 8 weeks
All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.
次要结局
- Change in Potassium(8 weeks)
- Change in Ambulatory Diastolic Blood Pressure(8 weeks)
- Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)(8 weeks)