Effects of Arterin Cholesterol for Reduction of Lipid Levels
Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 11, 2021
February 1, 2021
7 months
October 28, 2020
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-C levels between High Dose IP and placebo
Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline
12 weeks
Secondary Outcomes (14)
Difference LDL-C levels between Low Dose IP and placebo
12 weeks
Difference between combined IP vs. placebo
12 weeks
Difference between combined IP vs. placebo
12 weeks
Difference between combined IP vs. placebo
12 weeks
Difference between combined IP vs. placebo
12 weeks
- +9 more secondary outcomes
Other Outcomes (7)
Difference in tolerability parameters between groups
12 weeks
Difference in tolerability parameters between groups
12 weeks
Difference in tolerability parameters between groups
12 weeks
- +4 more other outcomes
Study Arms (3)
High dose IP
EXPERIMENTALTwo tablets IP daily for 12 weeks
Low dose IP
EXPERIMENTALOne tablet IP + one tablet placebo daily for 12 weeks
Placebo
PLACEBO COMPARATORTwo tablets placebo daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Males and females
- 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)
- Electrocardiogram (ECG) without pathological findings at V1
- Readiness and ability to comply with study requirements, in particular:
- to take IP as recommended
- to avoid the use of any nutritional, medical and further interventional options for reduction/maintenance of lipid levels during the study (other than the IP)
- to avoid consumption of grapefruit, but otherwise keep the dietary habits
- to keep the habitual level of physical activity during the study
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- Readiness not to participate in another clinical study during this study
You may not qualify if:
- 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
- untreated or non-stabilised hypertension (regular systolic blood pressure
- ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- untreated/non-stabilised diabetes mellitus type 1 or 2
- acute or chronic psychotic disorder
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Perrigo CSCIlead
- Analyze & Realizecollaborator
Study Sites (1)
analyze & realize GmbH
Berlin, 13467, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Ralf Uebelhack, MD
Analyze & Realize
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
February 11, 2021
Study Start
October 30, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
February 11, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share