CTRI/2009/091/000251
Completed
Phase 2
Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke
Gennova Biopharmaceuticals Limited Pune0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gennova Biopharmaceuticals Limited Pune
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS)
- •2\. Treatment within 3 hours of stroke onset
- •3\. Age 18 to 75 years
- •4\. Patient or legally acceptable representative willing to give informed consent before study procedure
Exclusion Criteria
- •1\. Minor stroke symptoms or major symptoms rapidly improving
- •2\. Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan
- •3\. Clinical presentation suggesting subarachnoid haemorrhage
- •4\. Pregnancy
- •5\. Known bleeding diathesis and/or platelet count \< 100 000 mm3
- •6\. Patient taking oral anticoagulants.
- •7\. Patients who have received heparin within 48 hours
- •8\. Major surgery or serious trauma within 14 days; serious head trauma within 3 months
- •9\. Gastrointestinal or urinary tract hemorrhage within 21 days
- •10\. Arterial puncture at a noncompressible site or lumbar puncture within 7 days
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Clinical trial of S-Metoprolol and Telmisartan combination tablet in the treatment of hypertensioCTRI/2011/06/001819Emcure Pharmaceuticals Ltd Pune200
Completed
Phase 3
A phase III clinical trial study to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in Acute Ischemic Stroke patientsCTRI/2015/02/005556Gennova Biopharmaceuticals Ltd62
Completed
Phase 3
Efficacy and safety of Fixed Dose Combination of Dexketoprofen Trometamol and Dicyclomine Hydrochloride InjectioCTRI/2010/091/001343Emcure Pharmaceuticals Ltd. Pune200
Not yet recruiting
Not Applicable
Clinical trial to evaluate the safety, efficacy, and economic feasibility of virtual reality-based ‘Emotion to Emotion Therapy’ for post-traumatic stress disorder patientsKCT0007845Wonkwang University Sanbon Hospital72
Recruiting
Not Applicable
Clinical trial to verify the efficacy and safety of improvement of lower extremity muscle function and balance therapy using Electric Orthopedic Exercise Device(WALK WELL™) in hemiplegic stroke patientsKCT0004558Chonbuk National University Hospital30