A phase 3 clinical trial to study the efficacy and safety of drug fasudil in comparison with nimodipine in patients with non-traumatic subarachnoid hemorrhage
- Conditions
- Health Condition 1: null- Non-traumatic subarachnoid hemorrhage
- Registration Number
- CTRI/2010/091/000422
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delayed Ischemic Neurological DeficitsTimepoint: During two weeks of treatment period
- Secondary Outcome Measures
Name Time Method 1) Neurological worsening <br/ ><br>2) Requirement of administration of a valid rescue therapy <br/ ><br>3) 3 or score of Modified Rankin Scale <br/ ><br> <br/ ><br>Timepoint: 1) During two weeks of treatment period <br/ ><br>2) During two weeks of treatment period <br/ ><br>3) At the end of study <br/ ><br>