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

Launched by CHONG KUN DANG PHARMACEUTICAL · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is researching two new medications, CKD-391 and CKD-331, to see how effective and safe they are for adults with a condition called primary hypercholesterolemia, which means they have high cholesterol levels that can lead to heart problems. The trial is currently looking for participants aged 19 and older who are willing to stop their current cholesterol-lowering treatments as part of the study. It's important for potential participants to note that this trial is not for those with other causes of high cholesterol or any serious health issues that could affect their cholesterol levels.

Participants in this trial can expect to take either CKD-391 or CKD-331 for a set period, and neither they nor their doctors will know which medication they are receiving, making it a "double-blind" study. This helps ensure that the results are unbiased. If you or someone you know is interested in participating, it’s a great opportunity to contribute to important research in managing high cholesterol while receiving close medical supervision throughout the study.

Gender

ALL

Eligibility 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

Trial Officials