NCT00732771已完成2 期
A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Systolic blood pressure over a 7-week forced titration treatment period
研究概览
简要总结
The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA).
- •Hypertension at screening
排除标准
- •Persistent hypokalemia
- •Renal impairment
- •Significant hepatic disease
- •Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCI696 1mg bid
Experimental
干预措施: LCI699 (Drug)
结局指标
主要结局
Systolic blood pressure over a 7-week forced titration treatment period
时间窗: 7 weeks
次要结局
- Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period(7 weeks)
研究者
研究点 (1)
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