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
ROMANTIC
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
1 other identifier
interventional
215
0 countries
N/A
Brief Summary
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedJanuary 20, 2017
January 1, 2017
1.8 years
January 16, 2017
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Variation rate of Non HDL-C
8 weeks
Secondary Outcomes (7)
Variation rate of TG
4 weeks, 8 weeks
Variation rate of Non HDL-C
4 weeks
Variation rate of TC
4 weeks, 8 weeks
Variation rate of LDL-C
4 weeks, 8 weeks
Variation rate of VLDL-C
4 weeks, 8 weeks
- +2 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALKI1107
Control
ACTIVE COMPARATORRosuvastatin calcium
Interventions
Eligibility Criteria
You may qualify if:
- Screening Visit
- Age: 19-80
- High risk for cardiovascular disease according to NCEP APT III
- TG≥130mg/dL and 160mg/dL\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
- mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks
- Baseline Visit
- mg/dL\>TG≥200mg/dL
- LDL-C\<110mg/dL
- Reduction of LDL-C dompairng screening visit
You may not qualify if:
- The patient has histories of acute artery disease within 3 months
- The patient has histories of operation revasculatiation or aneurysm within 6 months
- The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis
- The patient has histories of Effectable disease to the procedrue and clinical trial result
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Kim CH, Han KA, Yu J, Lee SH, Jeon HK, Kim SH, Kim SY, Han KH, Won K, Kim DB, Lee KJ, Min K, Byun DW, Lim SW, Ahn CW, Kim S, Hong YJ, Sung J, Hur SH, Hong SJ, Lim HS, Park IB, Kim IJ, Lee H, Kim HS. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.
PMID: 29223557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2017
First Posted
January 20, 2017
Study Start
May 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 20, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share