Status:
COMPLETED
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
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 with or without other...
Detailed Description
The maximum study duration was approximately 35 weeks per participant, including up to 3 weeks screening period, 24 weeks double-blind treatment period, and 8 weeks 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 with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3).
- Exclusion criteria:
- Aged \<18 years or legal age of adulthood, whichever was greater.
- Participants without established CHD or CHD risk equivalent.
- LDL-C \<70 mg/dL (\<1.81 mmol/L) in participants with a history of documented cardiovascular disease.
- LDL-C \<100 mg/dL (\<2.59 mmol/L) in participants without a history of documented cardiovascular disease.
- Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits.
- 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 20 mg or simvastatin 40 mg.
- 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 participants's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT02289963
Start Date
January 1 2015
End Date
April 1 2016
Last Update
June 26 2017
Active Locations (27)
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1
Investigational Site Number 410001
Anyang, South Korea, 431-070
2
Investigational Site Number 410009
Anyang-si, South Korea, 431-070
3
Investigational Site Number 410017
Busan, South Korea, 602-715
4
Investigational Site Number 410007
Busan, South Korea, 614-735