Trials / Completed
CompletedNCT03482180
Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 215 (actual)
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
Detailed description
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KI1106 4g, QD | KI1106 4 Capsules |
| DRUG | Atorvastatin Calcium 20mg, QD | Atorvastatin Calcium 20mg |
Timeline
- Start date
- 2016-05-04
- Primary completion
- 2017-05-16
- Completion
- 2018-03-23
- First posted
- 2018-03-29
- Last updated
- 2018-11-19
Source: ClinicalTrials.gov record NCT03482180. Inclusion in this directory is not an endorsement.