A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

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