- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01851759
Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
A Random, Double-blind, Placebo- Controlled and Dose-finding, Multi-center, Phase II Clinical Trial of Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710032
- Xijing Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age between 40 and 75 years old,male/ female;
- The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score <2 before this disease)
- Patients is proved by head skull CT and cerebral hemorrhage was excluded;
- course of disease≤72h,the NIHSS score is ≥7 and ≤22;
- Patients who voluntarily sign written informed consent. -
Exclusion Criteria:
- Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
- Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
- Patients who suffer from severe complications, and expected survival period is within three months.
- Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
- Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
- Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
- Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
- Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal(ALT,AST≥1.5 times of upper normal limit,Cr>upper normal limit).
- Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
- Patients who have complications of mental illness un can not or do not want willing to cooperate .
- Doubt or does have alcohol, drug abuse history
- Allergic constitution or allergic to the test drug ingredients .
- Pregnancy and lactation women or those who has a recent fertility plan
- Patients who have participated in other clinical experiments three months before this test.
- The patients who is unsuitable to participate in the clinical test in the view of researchers
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Cinepazide, Stroke, Injection
Test drug:Methanesulfonic acid cinepazide injection(5ml/125mg)
|
2 branches of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection was matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
Andra namn:
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Placebo-jämförare: palcebo,Stroke,Injection
Placebo:simulation agent of Methanesulfonic acid cinepazide injection(5ml sterile water for injection)
|
2 branches of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
modified Rankin scale
Tidsram: 3 month
|
3 month
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Barthel index
Tidsram: 3 month
|
3 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gang Zhao, Doctor, Xijing Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- xijing005
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