Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
1 other identifier
interventional
216
1 country
1
Brief Summary
This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 20, 2016
October 1, 2015
3.5 years
February 7, 2014
June 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
90 days
Secondary Outcomes (1)
To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.
90 days
Study Arms (2)
Pinocembrin for Injection
EXPERIMENTAL40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
placebo
PLACEBO COMPARATOR60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
Interventions
Eligibility Criteria
You may qualify if:
- hospitalized patients
- Patients with acute stroke ≤24h
- NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
- For the first time or always without obvious sequelae of stroke disease(mRS≤1）
- Informed consent
You may not qualify if:
- The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
- Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
- TIA
- Symptoms of disease rapidly improving during the randomized
- Severe hypertension(SBP \> 200 mmHg or DBP \>110 mmHg)
- Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance \<60ml/min）
- Severe system or viscera organic disease
- Have used other neuroprotectant or other experimental drugs
- Patient who are unlikely to complete the study that due to a severe clinical condition
- Pregnant or breast-feeding
- Participation in a previous clinical study within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital affilliated to Capital Medical University
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wang Yong Jun, Ph.D
Beijing Tiantan Hospital affilliated to Capital Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2014
First Posted
February 11, 2014
Study Start
June 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
June 20, 2016
Record last verified: 2015-10