CTRI/2020/06/025822已完成3 期
A Prospective, Interventional, Randomized, Double blind, multi-centric, comparative Clinical trial to evaluate the Efficacy and safety of NIMODIN IV infusion (Nimodipine) BP 50 ml with Nimotop IV infusion (Nimodipine) 50 ml for the treatment of hypertension in patients with intra-cerebral hemorrhage.
Swiss Parenterals Ltd2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年6月25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
- 80
- 试验地点
- 2
- 主要终点
- •To reduce and maintain the SBP between 120 and 140 mmhg.
研究概览
简要总结
A Prospective,Interventional, Randomized, Doubleblind, multi-centric, comparative Clinicaltrial to evaluate the Efficacy and safety of NIMODIN IV infusion (Nimodipine) BP 50 ml withNimotop IV infusion (Nimodipine)50 ml for the treatment of hypertension in patients with intra-cerebralhemorrhage.
Total 80 subjects will be enrolled in the study
Test (n=40) NIMODIN IV infusion (Nimodipine) BP 50 ml
Reference (n=40) Nimotop IV infusion (Nimodipine) 50 ml
The study duration will be total 21days (Depends on patients condition around 5 days or maximum 14 days treatment+ Follow up after 21 ±3 days of completion of treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and Female of Age: Between 18-75 years.
- •2.SAH (subarachnoid hemorrhage) which is diagnosed by the physician.
- •(CTA and CT-SCAN) 3.Patients whose elevated SBP (Systolic blood pressure) at admission reached >140 mmHg. 4.The total GCS (Glasgow Coma Scale) score of 10 to 15 at time of enrollment.
- •5.CT scan demonstrated intraparenchymal hematoma with manual hematoma volume measurement ,60 mL 6.Willing to give informed consent, if patient is not in the state to give informed consent then either patients or legal representative will be responsible to give informed consent.
排除标准
- •1.During the admission SBP >240 mmHg. 2.Intraventricular or infratentorial hemorrhage.
- •3.Clinical and radiological signs of brain herniation 4.TBI and aSAH (aneurysmal subarachnoid hemorrhage) 5.Patients with coagulopathy.
- •6.Uncontrollable irritability, pain, or other factors that affect BP.
- •7.Any history of congestive heart failure, renal failure, or liver damage.
- •8.Known sensitivity to nicardipine or nimodipine.
- •9.Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
- •10.Has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow the subject according to the protocol.
- •11.Pregnant and Breast feeding mother.
结局指标
主要结局
•To reduce and maintain the SBP between 120 and 140 mmhg.
时间窗: 3 hr, 6 hr, 8 hr, 12 hr and 24 hr after initiation of infusion
次要结局
- 1.To evaluate the changes of Neurological status by GCS scale.(2.To evaluate ICH values (Incidence of Hematoma expansion/volume) by CTA (Computed tomography angiography))
研究者
研究点 (2)
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