Primary Hypercholesterolemia
Conditions
Brief summary
This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia
Detailed description
Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥ 19 years of age * Primary hypercholesterolemia * Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator
Exclusion criteria
* Secondary hypercholesterolemia * Conditions / situations such as: 1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels 2. Severe renal impairment or active liver disease * History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes. * History of drug abuse or alcoholism within 24 weeks before screening * Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs * Patients who have been taken with other investigational drugs within 8 weeks before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change | Baseline, Week 8 | from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C) |
Countries
South Korea
Contacts
Primary ContactSeungHwan Lee, MD
Outcome results
None listed