Status:
COMPLETED
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Hypercholesterolaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised sett...
Detailed Description
Total study duration per participant was expected to be up to 18 weeks, with up to 2 weeks of screening period and 16 weeks of study treatment period.
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Participants were in either category A or B (below), and were not adequately controlled with a stable daily dose of atorvastatin (20 mg or 40 mg), or rosuvastatin (10 mg or 20 mg) for at least 4 weeks prior to the screening visit (Week -2), with or without other LMT:
- A. Participants with heterozygous familial hypercholesterolemia (heFH) (diagnosis based on either genotyping or clinical criteria) OR
- B. Non-FH Participants at high or very high cardiovascular (CV) risk. High and very high cardiovascular risk participants included participants with coronary heart disease (CHD), non-CHD cardiovascular disease (CVD), and other risk factors.
- Participant willing and able to self-inject for the duration of the study.
- Exclusion criteria:
- LDL-C \<70 milligrams per deciliter (mg/dL) (\<1.81 millimoles per litre \[mmol/L\]) at the screening visit.
- Currently taking a daily dose of statin that was not atorvastatin 20 mg or 40 mg, or rosuvastatin 10 mg or 20 mg.
- Not on a stable dose of LMT (including statin) for at least 4 weeks, prior to the screening visit and from screening to randomization.
- Having previously used any device for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor administration, or having participated in any clinical trial for a PCSK9 inhibitor.
- Fasting serum Triglyceride (TG) \>400 mg/dL (\>4.52 mmol/L) at the screening visit.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2018
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03415178
Start Date
March 29 2018
End Date
August 9 2018
Last Update
September 9 2019
Active Locations (13)
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1
Investigational Site Number 8400024
Los Angeles, California, United States, 90057
2
Investigational Site Number 8400007
Jacksonville, Florida, United States, 32216
3
Investigational Site Number 8400017
Jacksonville, Florida, United States, 32223
4
Investigational Site Number 8400013
Ponte Vedra, Florida, United States, 32081