Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02166593
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2014-05-27
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin
Sponsor:
Yooyoung Pharmaceutical Co Ltd
Organization:
Yooyoung Pharmaceutical Co Ltd
Study Overview
Official Title:
A Study to Evaluate the Efficacy and Safety of PravastatinFenofibrate Complex in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
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:
1 Target disease Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy
2 Study objective The objective of this study is to demonstrate that Pravafenix Cap is clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each group after 8 weeks treatment with atorvastatin or Pravafenix Cap pravastatin sodiumfenofibrate in patients with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy in a multicenter randomized double blind setting
3 Phase and design A multicenter double blind randomized active controlled parallel-design Phase 3 study
4 Duration of study 12 months from the IRB approval date
5 Duration of administration 4-week single blind run-in period plus 8-week double blind treatment period
2 Study objective The objective of this study is to demonstrate that Pravafenix Cap is clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each group after 8 weeks treatment with atorvastatin or Pravafenix Cap pravastatin sodiumfenofibrate in patients with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy in a multicenter randomized double blind setting
3 Phase and design A multicenter double blind randomized active controlled parallel-design Phase 3 study
4 Duration of study 12 months from the IRB approval date
5 Duration of administration 4-week single blind run-in period plus 8-week double blind treatment period
Detailed Description:
This study is to Evaluate the Efficacy and Safety of PravastatinFenofibrate Complex in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy After administrating the atorvastatin or Pravafenix Cap pravastatin sodiumfenofibrate for 8 weeks evaluate the variation of the Non-HDL-C for each arm Ultimatly verificaite the Pravafenix Cap pravastatin sodiumfenofibrate have better effects than atorvastatin
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