Phase 3
Completed N=199
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
Source: ClinicalTrials.gov NCT02289963 ↗Enrolled (actual)
199
Serious AEs
13.6%
Results posted
Jun 2017
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis — 6.3; -57.1 percent change — p=<0.0001
◆ Published Evidence
Highly cited
126citations · ~21 / year
PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
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 lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.
Secondary Objectives:
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies (ADA).
Linked Publications (3)
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PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
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A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT).
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A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis |
6.3; -57.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
6.0; -60.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
4.7; -57.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
4.7; -58.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
4.1; -42.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis |
3.8; -45.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
4.3; -47.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis |
4.1; -50.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
4.0; -31.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
5.2; -40.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
3.9; -47.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
2.8; -32.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
14.2; 85.8 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis |
14.1; 88.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
-2.251; -35.862 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis |
6.2; 13.8 | 0.0029 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
-3.627; -8.143 | 0.3110 |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis |
3.2; 4.5 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis |
-1.676; -33.601 | — |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
2.0; 7.1 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
2.113; -6.999 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
1.5; 4.5 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02289963) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.