CTRI/2011/07/001922已完成3 期
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Kallikrein versus placebo alongwith standard supportive care in subjects of mild to moderate ischecmic stroke.
Bharat Serums and Vaccines Ltd11 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年4月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration
研究概览
简要总结
The study is a randomised, placebo controlled double-blind study to determine the efficacy and safety of Kallikrein as adjuvant therapy in treatment of mild to moderate ischemic strokes at a dose of 0.15 PNA o.d for 10 days. This study will be conducted in 8-10 centers in India. The primary efficacy variables will be Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration and 90 Day Mortality. The secondary efficacy variables will be reduction in disability as measured by scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild to moderate cerebral ischemic strokes presenting within 48 hours after onset of symptoms.
- •(NIHSS score: 4-10, mild; 11-20, moderate)
- •Male or female, aged 18 to 70 years (both inclusive)
- •No hemorrhage as proved by cerebral CT scan.
排除标准
- •Mean arterial blood pressure > 180/110
- •NIHSS score: >
- •Age <18 or >70 years
- •History of dementia or neurodegenerative disease
- •Severe comorbid condition such as cancer that would limit survival during 3 month follow-up period
- •Women of childbearing potential
- •Peptic ulcer disease, Active bleeding diathesis, Lower GI bleed
- •Hematuria
- •Prolonged PT or PTT, Thrombocytopenia or neutropenia
- •Elevated LFT / RFT.
结局指标
主要结局
Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration
时间窗: Day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration
次要结局
- Reduction in disability as measured by combined Barthel Index & modified Rankin's scale.(Day 5, day 11, day 30, day 60 and day 90 from day 1 of IP administration)
研究者
研究点 (11)
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