Status:
COMPLETED
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezet...
Detailed Description
The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at a stable dose for at least 4 weeks prior to the screening visit (Week -3).
- Exclusion criteria:
- Participants without established CHD or CHD risk equivalents.
- LDL-C \<70 mg/dL (\<1.81 mmol/L) at the screening visit (Week -3) in participants with history of documented CV disease.
- LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit (Week -3) in participants without history of documented CV disease.
- Change in statin dose or dose regimen from screening to randomization.
- Currently taking a statin other than atorvastatin, rosuvastatin, or simvastatin.
- Atorvastatin, rosuvastatin, or simvastatin was not taken daily or not taken at a registered dose.
- Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg.
- Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty acid (at doses ≥1000 mg daily), nicotinic acid, fibrates, bile acid-binding sequestrant, or red yeast rice products in the past 4 weeks prior to screening visit (Week -3).
- Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) at the screening period.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2018
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT02715726
Start Date
July 27 2016
End Date
August 6 2018
Last Update
September 30 2019
Active Locations (62)
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1
Investigational Site Number 1560027
Beijing, China, 100029
2
Investigational Site Number 1560043
Beijing, China, 100034
3
Investigational Site Number 1560039
Beijing, China, 100053
4
Investigational Site Number 1560012
Beijing, China, 100730