Status:
UNKNOWN
Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia
Lead Sponsor:
CVI Pharmaceuticals
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg ...
Detailed Description
This study is a phase II study in subjects with elevated LDL cholesterol. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions ...
Eligibility Criteria
Inclusion
- Key
- 1\. Aged 18-70 years, inclusive
- 2\. Men and nonpregnant, nonlactating women
- 3\. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L\~4.88mmol/L at screening, inclusive
Exclusion
- 1\. Fasting TG ≥3.99 mmol/L before randomization
- 2\. History of significant cardiovascular , renal, pulmonary and liver diseases
- 3\. History of diabetes
- 4\. ALT or AST\>1.5XULN at screening
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04438096
Start Date
July 15 2020
End Date
March 15 2022
Last Update
June 23 2020
Active Locations (1)
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1
The second affiliated hospital of zhejiang University school of medicine
Hangzhou, China, 310009