Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-04-23 @ 7:51 PM
Study NCT ID:
NCT03026933
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2017-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Sponsor:
Kuhnil Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Status:
COMPLETED
Status Verified Date:
2017-01
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:
ROMANTIC
Brief Summary:
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
Detailed Description:
Study design:
Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.
Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.
Study Oversight
Has Oversight DMC:
False
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?: