Hypercholesterolemia
Conditions
Keywords
LDL Cholesterol Reduction
Brief summary
A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides
Detailed description
A multicenter study to evaluate efficacy and safety
Interventions
DRUGPitavastatin 4mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
DRUGEzetimibe 10 mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
DRUGPlacebo (for Pitavastatin/Ezetimibe)
Administered as a matching placebo tablet identical in appearance to the Pitavastatin/Ezetimibe 4/10 mg fixed-dose combination, orally once daily for 52 weeks.
DRUGPlacebo (for Pitavastatin)
Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks.
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
To maintain the double-blind, a double-dummy method was used where participants received both an active tablet and a matching placebo of the comparator
Intervention model description
randomized, double-blind, phase IV
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with hypercholesterolemia * Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C
Exclusion criteria
* New-onset acute cardio-cerebrovascular disease * Severe hepatic impairment * Active liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment | Baseline to week 8 | The unit of measure is percentage (%). The percentage change is calculated as: \[(Value at Week 8 - Value at Baseline) / Value at Baseline\] \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment | Baseline to week 8, 24, 52 | Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL |
| Change from baseline in Triglycerides at Weeks 8, 24, and 52 after the first dose of study treatment | Baseline to week 8, 24, 52 | Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL |
| Change from baseline in LDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment | Baseline to week 8, 24, 52 | Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL |
| Change from baseline in Non-alcoholic Fatty Liver Disease Liver Fat Score (NLFS) at Weeks 24 and 52 | Baseline to week 24, 52 | The NLFS is a calculated score used to estimate liver fat content. The change is calculated as (Value at Week 24 or 52) - (Value at Baseline). |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHyuk Sang Kwon
The Catholic University of Korea, Yeouido St. Mary's Hospital, Principal Investigator
Outcome results
None listed