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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

Trial Information

Current as of January 22, 2025

Unknown status

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

SeungHwan Lee, MD

Principal Investigator

Asan Medical Center

About Chong Kun Dang Pharmaceutical

Chong Kun Dang Pharmaceutical is a leading South Korean pharmaceutical company dedicated to the research, development, manufacturing, and marketing of innovative healthcare solutions. With a strong emphasis on quality and efficacy, the company specializes in a diverse range of therapeutic areas, including oncology, cardiology, and neurology. Chong Kun Dang is committed to advancing patient care through clinical trials that adhere to the highest ethical standards, leveraging cutting-edge technology and scientific expertise to bring new treatments to market. Its robust pipeline and collaborative approach position the company as a key player in the global pharmaceutical landscape.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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