Ignite Creation Date:
2024-05-06 @ 7:26 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02532309
Status:
UNKNOWN
Last Update Posted:
2015-08-28
First Post:
2015-07-30
Brief Title:
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques
Sponsor:
Wei Liu
Organization:
China-Japan Friendship Hospital
Study Overview
Official Title:
A 2-year Open-label Randomized Study to Evaluate the Efficacy of Rosuvastatin Dosing Adjustment by LDL-C Level Compared to That of 5mg Maintenance Dose in Chinese Patients With Carotid Atherosclerotic Plaques
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 2-year open-label randomized study to evaluate the efficacy of Rosuvastatin dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients with Carotid Atherosclerosis
Detailed Description:
This will be a 2-year randomized open-label prospective parallel-group study It only be held in China-Japan Friendship Hospital Subjects with Carotid Atherosclerosis Plaques who meet all inclusion and none of the exclusion criteria will be randomized in a 11 ratio to receive treatment of rosuvastatin 5 mg 10mg 20mg dosing adjustment by LDL-c level or fixed dose 5 mg The study will consist of two phases the ScreeningBaseline period-1to week 0and the Follow-up period0 to month 24 The follow-up period will comprise seven visits
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