Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648304
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed as a multi-center randomized double-blind parallel placebo-controlled trial to evaluate the efficacy and safety of TTYP01 tablets in the treatment of acute ischemic stroke
Detailed Description:
A multicenter randomized double-blind parallel placebo-controlled trial design is used to evaluate the efficacy and safety of TTYP01 tablets in the treatment of patients with acute ischemic stroke
It is estimated that 618 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 11 ratio with 309 patients in each group Normally the duration of this study is approximately 90 days This study will be divided into 2 periods with a total of five visits Treatment observation period D1 D28 the minimum length of in-hospital observation will be not less than 7 days including 3 visits V1- V3 follow-up period D29 D90 including 2 visits V4 D60 5 for telephone follow-up V5 D90 5 returning to hospital for end-of-study visit
It is estimated that 618 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 11 ratio with 309 patients in each group Normally the duration of this study is approximately 90 days This study will be divided into 2 periods with a total of five visits Treatment observation period D1 D28 the minimum length of in-hospital observation will be not less than 7 days including 3 visits V1- V3 follow-up period D29 D90 including 2 visits V4 D60 5 for telephone follow-up V5 D90 5 returning to hospital for end-of-study visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None