An open label, randomized, parallel group, prospective, multicentre clinical trial for evaluation of efficacy and safety of fasudil hydrochloride in comparison with nimodipine following non-traumatic subarachnoid hemorrhage

Intas Pharmaceuticals Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1)Either sex, age between 18 and 70 years hospitalized with non-traumatic SAH (subarachnoid hemorrhage)
•2)In case of females with child bearing potential, negative serum pregnancy test at screening and willing to use medically acceptable contraceptive through out the study period
•3)Himself/herself or his/her legally accepted representative willing to provide written informed consent
•4)For whom study medication can be started within 56 hours of detection of SAH

•1)Recent history of stroke or subarachnoid hemorrhage
•2)Patients with hypotension (systolic blood pressure (SBP) < or = 90 mm Hg) at baseline
•3)Patient with serious disturbance of consciousness, patient with subarachnoid hemorrhage combined with serious cerebrovascular damage
•4)Patients with presence of cerebral edema and severely raised intracranial pressure at screening
•5)Ongoing lactation
•6)Patients with pulmonary edema or severe cardiac failure requiring inotropic support at the time of randomization
•7)Hepatic function impairment (SGPT or SGOT level > or = 2.5 times upper normal limit) or renal function impairment (serum creatinine > or = 1.5 times upper normal limit)
•8)Ongoing use of prohibited medications ? vasodilators, nephrotoxic drugs, inhibitors of CYP 3A4, intravenous beta blockers
•9)As deemed inappropriate for enrollment by investigating physician due to other reasons

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