Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

This study has suspended participant recruitment.

Sponsor:

Information provided by (Responsible Party):

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02059785

First received: February 7, 2014

Last updated: June 16, 2016

Last verified: October 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2014

Last Updated Date

June 16, 2016

Start Date ^ICMJE

June 2013

Estimated Primary Completion Date

December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days [ Time Frame: 90 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02059785 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare treatment arms in terms of change from baseline to endpoint in NIHSS score. [ Time Frame: 90 days ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Official Title ^ICMJE

Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study

Brief Summary

This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Detailed Description

Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Ischemic Stroke

Intervention ^ICMJE

Drug: Pinocembrin for Injection

Other Name: DL0108

Study Arms

Experimental: Pinocembrin for Injection
40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Intervention: Drug: Pinocembrin for Injection
Placebo Comparator: placebo
60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Intervention: Drug: Pinocembrin for Injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

216

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

35-75 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

Exclusion Criteria:

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
Meets all other exclusion criteria

Sex/Gender

Sexes Eligible for Study:

All

Ages

35 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02059785

Other Study ID Numbers ^ICMJE

CSPC-HA1301

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study Sponsor ^ICMJE

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Wang Yong Jun, Ph.D

Beijing Tiantan Hospital affilliated to Capital Medical University

PRS Account

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Verification Date

October 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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