Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

NCT ID: NCT02059785

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pinocembrin for Injection

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

Group Type: EXPERIMENTAL

Pinocembrin for Injection

Intervention Type: DRUG

placebo

60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Group Type: PLACEBO_COMPARATOR

Pinocembrin for Injection

Intervention Type: DRUG

Interventions

Pinocembrin for Injection

Intervention Type: DRUG

Other Intervention Names

DL0108

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang Yong Jun, Ph.D

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital affilliated to Capital Medical University

Locations

Beijing Tiantan Hospital affilliated to Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CSPC-HA1301

Identifier Type: -

Identifier Source: org_study_id