Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | KI1107 |
|
| Control | Active Comparator | Rosuvastatin calcium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KI1107 4 Capsules, QD | Drug | KI1107 4 Capsules |
| |
| Rosuvastatin Calcium 20 MG, QD |
| Measure | Description | Time Frame |
|---|---|---|
| Variation rate of Non HDL-C | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Variation rate of TG | 4 weeks, 8 weeks | |
| Variation rate of Non HDL-C | 4 weeks | |
| Variation rate of TC |
Not provided
Inclusion criteria:
Screening Visit
Baseline Visit
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29223557 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Rosuvastatin Calcium 20mg, QD |
|
| 4 weeks, 8 weeks |
| Variation rate of LDL-C | 4 weeks, 8 weeks |
| Variation rate of VLDL-C | 4 weeks, 8 weeks |
| Variation rate of Apo A-I | 4 weeks, 8 weeks |
| Variation rate of Apo B | 4 weeks, 8 weeks |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided