Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels

Perrigo CSCI1 site in 1 country114 target enrollmentOctober 30, 2020

ConditionsBlood Cholesterol Lowers LDL-C

Overview

Phase: N/A
Intervention: Not specified
Conditions: Blood Cholesterol Lowers
Sponsor: Perrigo CSCI
Enrollment: 114
Locations: 1
Primary Endpoint: LDL-C levels between High Dose IP and placebo
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this double-blind, randomised, placebo-controlled study is to assess the benefit and tolerability of Arterin Cholesterol in subjects with elevated lipid levels within a 12-week period of use.

Registry

clinicaltrials.gov

Start Date

October 30, 2020

End Date

June 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Perrigo CSCI

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females
•18 to 65 years old
•BMI 25 - 29.9 kg/m2
•Generally in good health
•LDL-C level between 3.359-4.884 mmol/L (130-189 mg/dL)
•Stable body weight for at least 3 months prior to study inclusion (\<3 kg weight change) (self-reported)
•Not smoking, at least 6 months prior to study inclusion and throughout the study
•Electrocardiogram (ECG) without pathological findings at V1
•Readiness and ability to comply with study requirements, in particular:
•to take IP as recommended

Exclusion Criteria

•Known allergy or hypersensitivity to the components of the investigational product
•LDL-C level ≥4.910 mmol/L (≥190 mg/dL)
•Total cholesterol level ≥7.254 mmol/L (≥280 mg/dL)
•Triglyceride level ≥2.851 mmol/L (≥250 mg/dL)
•HDL-C level \<1.034 mmol/L (\<40 mg/dL)
•Known genetic hyperlipidemia
•Known family history of dyslipidemia
•History and/or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
•cardiovascular disease/disorder (myocardial infarction, angina pectoris, stroke, heart failure, arrhythmia) within 6 months or requiring percutaneous coronary intervention or coronary artery bypass surgery
•untreated or non-stabilised thyroid gland disorder