Hyperlipidemias
Conditions
Brief summary
To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.
Detailed description
An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 19≤ * Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion criteria
* History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3 * Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean rate of change of non-HDL-C (%) from baseline | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean rate of change of HDL-C (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of LDL-C (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of Triglyceride (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of Total cholesterol (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of Total apo A1 (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of Total apo B (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of Lipoprotein(a) (%) from baseline | 4, 8, 12 weeks | — |
| Mean rate of change of hs-CRP (%) from baseline | 4, 8, 12 weeks | — |
| Rate of the subjects who meet the target level of treatment | 4, 8, 12 weeks | target level (Non-HDL-C\<130mg/dL) |
Countries
South Korea
Contacts
Primary ContactChang-Hee Jung
Outcome results
None listed