Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01576484
Collaborator
Sanofi (Industry)
58
14
2
57.8
4.1
0.1
Study Details
Study Description
Brief Summary
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
58 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 Administered by Subcutaneous Injection in Patients With Heterozygous Familial Hypercholesterolemia
Actual Study Start Date
:
Feb 28, 2012
Actual Primary Completion Date
:
Dec 22, 2016
Actual Study Completion Date
:
Dec 22, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Matched to Alirocumab Participants who received placebo in parent study (NCT01576484), has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study. |
Drug: Placebo Matched to Alirocumab
Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
|
| Experimental: Alirocumab 150 mg Participants who received alirocumab in parent study (NCT01576484), has received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. |
Drug: Alirocumab
Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death [Baseline (Day 1 of current study) to end of study (Week 218)]
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Secondary Outcome Measures
- Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 [Baseline (current study) to Week 24]
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 [Baseline (current study) up to Week 12]
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 [Baseline(current study) up to Week 24]
Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 [Baseline (current study) up to Week 12]
Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 [Baseline (current study) up to Week 52]
Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 [At Week 24]
Percentage of participants reaching LDL-C goal (ie, LDL-C <70 mg/dL (1.81 millimoles per liter [mmol/L]) in case of prior MI/stroke, or <100 mg/dL [2.59 mmol/L] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
- Percent Change in Lipoprotein a (Lp[a]) at Week 24 [At Week 24]
Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
- Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 [At Week 24 and 12]
Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
- Percent Change in Lipoprotein a at Week 12 [At Week 12]
Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
- Percent Change in Triglycerides (TG) at Week 24 and Week 12 [At Week 24 and 12]
Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
- Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 [At Week 24 and Week 12]
Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
- Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment [Baseline (current study) to the End of Treatment (Week 208)]
Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment [At Week 12, 52 and End of Treatment (Week 208)]
Percentage of participants reaching LDL-C goal (ie, LDL-C <70 mg/dL (1.81 millimoles per liter [mmol/L]) in case of prior MI/stroke, or <100 mg/dL [2.59 mmol/L] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
- Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment [Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)]
Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment [Baseline (current study) up to Weeks 52 and End of Treatment (Week 208)]
Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. [Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)]
Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment [At Week 12, 24, 52, and End of Treatment (Week 208)]
Percentage of participants was calculated with Apo B <80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment [At Week 12, 24, 52, and End of Treatment (Week 208)]
Percentage of participants was calculated with non-HDL-C <100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
- Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment [At Week 12, 24, 52, and End of Treatment (Week 208)]
Percentage of Participants was calculated with LDL-C <70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Prior participation in and the successful completion of the R727-CL-1003 study (NCT01266876).
-
Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study
-
A negative urine pregnancy at the screening/baseline visit for women of childbearing potential
Key Exclusion Criteria:
-
Reported a drug-related serious adverse event (SAE) or drug-related clinical or laboratory adverse event (AE) in the R727-CL-1003 study that resulted in early termination or withdrawal
-
Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient
-
Low-density lipoprotein (LDL) apheresis within 12 months before the screening/baseline visit
Note: Other exclusion criteria applied
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mission Viejo | California | United States | ||
| 2 | Newport Beach | California | United States | ||
| 3 | Thousand Oaks | California | United States | ||
| 4 | Miami | Florida | United States | ||
| 5 | Port Orange | Florida | United States | ||
| 6 | Kansas City | Kansas | United States | ||
| 7 | Auburn | Maine | United States | ||
| 8 | Saint Louis | Missouri | United States | ||
| 9 | Durham | North Carolina | United States | ||
| 10 | Cincinnati | Ohio | United States | ||
| 11 | Houston | Texas | United States | ||
| 12 | Chicoutimi | Quebec | Canada | ||
| 13 | Montreal | Quebec | Canada | ||
| 14 | Sainte-Foy | Quebec | Canada |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Sanofi
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01576484
Other Study ID Numbers:
- R727-CL-1032
First Posted:
Apr 12, 2012
Last Update Posted:
Aug 5, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 15 sites in the United States and Canada between 28 Feb 2012 and 22 Dec 2016. A total of 59 participants were screened in the study. |
|---|---|
| Pre-assignment Detail | Out of 59, 58 participants received alirocumab in this open-label extension study. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study |
|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. |
| Period Title: Overall Study | ||
| STARTED | 12 | 46 |
| COMPLETED | 7 | 27 |
| NOT COMPLETED | 5 | 19 |
Baseline Characteristics
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | Total |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Total of all reporting groups |
| Overall Participants | 12 | 46 | 58 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
54.9
(9.7)
|
54.3
(9.4)
|
54.4
(9.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
50%
|
14
30.4%
|
20
34.5%
|
| Male |
6
50%
|
32
69.6%
|
38
65.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
16.7%
|
2
4.3%
|
4
6.9%
|
| Not Hispanic or Latino |
10
83.3%
|
44
95.7%
|
54
93.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
8.3%
|
0
0%
|
1
1.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
4.3%
|
2
3.4%
|
| White |
11
91.7%
|
44
95.7%
|
55
94.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death |
|---|---|
| Description | An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. |
| Time Frame | Baseline (Day 1 of current study) to end of study (Week 218) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set (SAF) included all participants who received at least 1 dose or part of a dose of alirocumab. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Adverse Events |
12
100%
|
42
91.3%
|
54
93.1%
|
| Serious Adverse Events |
4
33.3%
|
8
17.4%
|
12
20.7%
|
| Adverse Events Leading to Death |
0
0%
|
0
0%
|
0
0%
|
| Title | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 |
|---|---|
| Description | Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 11 | 44 | 55 |
| Mean (Standard Deviation) [percent change] |
-73.15
(15.01)
|
-63.40
(22.04)
|
-65.35
(21.07)
|
| Title | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 |
|---|---|
| Description | Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 44 | 56 |
| Mean (Standard Deviation) [percent change] |
-55.93
(29.53)
|
-63.94
(23.35)
|
-62.22
(24.73)
|
| Title | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 |
|---|---|
| Description | Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline(current study) up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Apo B |
-52.23
(20.30)
|
-50.52
(18.18)
|
-50.86
(18.43)
|
| Non-HDL-C |
-56.75
(21.80)
|
-55.43
(20.97)
|
-55.71
(20.95)
|
| Total cholesterol |
-42.72
(15.30)
|
-41.47
(16.37)
|
-41.74
(16.02)
|
| Title | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 |
|---|---|
| Description | Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Apo- B |
-40.69
(30.46)
|
-48.78
(20.24)
|
-47.16
(22.56)
|
| Non-HDL- C |
-47.81
(32.92)
|
-54.97
(22.85)
|
-53.44
(25.18)
|
| Total Cholesterol |
-36.78
(24.88)
|
-40.47
(16.93)
|
-39.68
(18.72)
|
| Title | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 |
|---|---|
| Description | Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) up to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 42 | 54 |
| Mean (Standard Deviation) [percent change] |
-54.57
(26.20)
|
-55.67
(34.41)
|
-55.43
(32.53)
|
| Title | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 |
|---|---|
| Description | Percentage of participants reaching LDL-C goal (ie, LDL-C <70 mg/dL (1.81 millimoles per liter [mmol/L]) in case of prior MI/stroke, or <100 mg/dL [2.59 mmol/L] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported. |
| Time Frame | At Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 11 | 44 | 55 |
| Number [Percentage of Participants] |
100.00
833.3%
|
90.91
197.6%
|
92.73
159.9%
|
| Title | Percent Change in Lipoprotein a (Lp[a]) at Week 24 |
|---|---|
| Description | Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Time Frame | At Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 11 | 44 | 55 |
| Mean (Standard Deviation) [percent change] |
-27.91
(23.62)
|
-29.41
(25.01)
|
-29.11
(24.53)
|
| Title | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 |
|---|---|
| Description | Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Time Frame | At Week 24 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 24 |
2.61
(15.75)
|
7.14
(16.04)
|
6.17
(15.94)
|
| Week 12 |
1.46
(14.08)
|
10.43
(15.98)
|
8.51
(15.91)
|
| Title | Percent Change in Lipoprotein a at Week 12 |
|---|---|
| Description | Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Time Frame | At Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Matched to R727 | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 11 | 44 | 55 |
| Mean (Standard Deviation) [percent change] |
-20.30
(24.10)
|
-26.98
(22.71)
|
-25.64
(22.92)
|
| Title | Percent Change in Triglycerides (TG) at Week 24 and Week 12 |
|---|---|
| Description | Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Time Frame | At Week 24 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 24 |
0.19
(54.71)
|
-2.01
(41.22)
|
-1.54
(43.91)
|
| Week 12 |
-6.40
(46.11)
|
0.52
(34.17)
|
-0.96
(36.69)
|
| Title | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 |
|---|---|
| Description | Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Time Frame | At Week 24 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 24 |
5.41
(11.96)
|
4.78
(11.20)
|
4.91
(11.24)
|
| Week 12 |
11.10
(11.43)
|
8.64
(10.99)
|
9.13
(11.02)
|
| Title | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment |
|---|---|
| Description | Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) to the End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 3 | 14 | 17 |
| Mean (Standard Deviation) [percent change] |
-52.20
(16.86)
|
-58.46
(23.51)
|
-57.36
(22.15)
|
| Title | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment |
|---|---|
| Description | Percentage of participants reaching LDL-C goal (ie, LDL-C <70 mg/dL (1.81 millimoles per liter [mmol/L]) in case of prior MI/stroke, or <100 mg/dL [2.59 mmol/L] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported. |
| Time Frame | At Week 12, 52 and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 12 |
83.33
694.4%
|
90.91
197.6%
|
89.29
153.9%
|
| Week 52 |
75.00
625%
|
83.33
181.2%
|
81.48
140.5%
|
| End of Treatment (Week 208) |
100
833.3%
|
85.71
186.3%
|
88.24
152.1%
|
| Title | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment |
|---|---|
| Description | Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 12 |
-92.0
(54.3)
|
-96.8
(44.7)
|
-95.8
(46.4)
|
| Week 24 |
-113.2
(24.9)
|
-95.3
(40.0)
|
-98.9
(37.9)
|
| Week 52 |
-87.0
(44.5)
|
-83.8
(58.6)
|
-84.5
(55.4)
|
| Week 208 |
-80.3
(38.7)
|
-78.1
(33.6)
|
-78.5
(33.2)
|
| Title | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment |
|---|---|
| Description | Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) up to Weeks 52 and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Apo B : Week 52 |
-43.04
(25.60)
|
-45.17
(28.51)
|
-44.73
(27.71)
|
| Apo B : Week 208 |
-45.02
(17.58)
|
-48.07
(18.61)
|
-47.53
(17.93)
|
| Non- HDL-C: Week 52 |
-47.10
(27.26)
|
-48.60
(31.71)
|
-48.27
(30.54)
|
| Non- HDL-C: Week 208 |
-43.29
(17.98)
|
-50.34
(21.40)
|
-49.10
(20.50)
|
| Total -C : Week 52 |
-35.09
(19.16)
|
-36.41
(24.89)
|
-36.11
(23.57)
|
| Total -C : Week 208 |
-35.33
(11.92)
|
-37.01
(16.59)
|
-36.72
(15.55)
|
| Lp-(a): Week 52 |
-24.77
(25.14)
|
-22.91
(30.33)
|
-23.30
(29.11)
|
| Lp-(a): Week 208 |
-23.92
(39.92)
|
-31.29
(30.20)
|
-29.99
(30.80)
|
| HDL-C: Week 52 |
5.40
(17.64)
|
7.74
(14.21)
|
7.22
(14.89)
|
| HDL-C: Week 208 |
-9.83
(12.49)
|
4.94
(11.25)
|
2.34
(12.49)
|
| TG : Week 52 |
-6.04
(41.12)
|
-3.84
(40.25)
|
-4.33
(40.07)
|
| TG : Week 208 |
16.69
(28.93)
|
-5.28
(23.05)
|
-1.40
(24.71)
|
| Apo A-1 : Week 52 |
6.76
(10.82)
|
3.90
(10.80)
|
4.49
(10.76)
|
| Apo A-1 : Week 208 |
-1.46
(4.48)
|
9.53
(7.45)
|
7.59
(8.14)
|
| Title | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. |
|---|---|
| Description | Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 44 | 56 |
| Change at Week 12 |
-0.397
(0.234)
|
-0.456
(0.230)
|
-0.444
(0.230)
|
| Change at Week 24 |
-0.450
(0.162)
|
-0.460
(0.211)
|
-0.458
(0.201)
|
| Change at Week 52 |
-0.385
(0.210)
|
-0.416
(0.295)
|
-0.410
(0.278)
|
| Change at Week 208 |
-0.330
(0.165)
|
-0.402
(0.164)
|
-0.389
(0.161)
|
| Title | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment |
|---|---|
| Description | Percentage of participants was calculated with Apo B <80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | At Week 12, 24, 52, and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 12 |
66.67
555.6%
|
79.55
172.9%
|
76.79
132.4%
|
| Week 24 |
91.67
763.9%
|
81.82
177.9%
|
83.93
144.7%
|
| Week 52 |
66.67
555.6%
|
73.81
160.5%
|
72.22
124.5%
|
| Week 208 |
100.00
833.3%
|
85.71
186.3%
|
88.24
152.1%
|
| Title | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment |
|---|---|
| Description | Percentage of participants was calculated with non-HDL-C <100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | At Week 12, 24, 52, and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 12 |
58.33
486.1%
|
75.00
163%
|
71.43
123.2%
|
| Week 24 |
91.67
763.9%
|
81.82
177.9%
|
83.93
144.7%
|
| Week 52 |
58.33
486.1%
|
73.81
160.5%
|
70.37
121.3%
|
| Week 208 |
66.67
555.6%
|
78.57
170.8%
|
76.47
131.8%
|
| Title | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment |
|---|---|
| Description | Percentage of Participants was calculated with LDL-C <70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Time Frame | At Week 12, 24, 52, and End of Treatment (Week 208) |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category. |
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | All participants who received placebo or alirocumab in the parent study (NCT01576484). |
| Measure Participants | 12 | 46 | 58 |
| Week 12 |
66.67
555.6%
|
86.36
187.7%
|
82.14
141.6%
|
| Week 24 |
100.00
833.3%
|
81.82
177.9%
|
85.45
147.3%
|
| Week 52 |
75.00
625%
|
73.81
160.5%
|
74.07
127.7%
|
| Week 208 |
66.67
555.6%
|
85.71
186.3%
|
82.35
142%
|
Adverse Events
| Time Frame | All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period. | |||
| Arm/Group Title | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | ||
| Arm/Group Description | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | ||
All Cause Mortality |
||||
| Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/46 (0%) | ||
Serious Adverse Events |
||||
| Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/12 (33.3%) | 8/46 (17.4%) | ||
| Cardiac disorders | ||||
| Angina unstable | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Aortic valve stenosis | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Atrial fibrillation | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Atrial flutter | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Coronary artery disease | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Gastrointestinal disorders | ||||
| Colitis ischaemic | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Gastrooesophageal reflux disease | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Intestinal obstruction | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Infections and infestations | ||||
| Gastrointestinal viral infection | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Thermal burn | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 0/12 (0%) | 0 | 1/46 (2.2%) | 1 |
| Nervous system disorders | ||||
| Amnesia | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Carotid artery disease | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Psychiatric disorders | ||||
| Neuropsychiatric symptoms | 1/12 (8.3%) | 2 | 0/46 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/12 (100%) | 38/46 (82.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/12 (8.3%) | 1 | 2/46 (4.3%) | 2 |
| Cardiac disorders | ||||
| Angina pectoris | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Aortic valve stenosis | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Ischaemic cardiomyopathy | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Cerumen impaction | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Ear pain | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Tinnitus | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Eye disorders | ||||
| Cataract | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 2 |
| Eyelid oedema | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/12 (8.3%) | 1 | 2/46 (4.3%) | 2 |
| Anorectal discomfort | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Diarrhoea | 2/12 (16.7%) | 2 | 6/46 (13%) | 8 |
| Dyspepsia | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Eructation | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/12 (8.3%) | 1 | 3/46 (6.5%) | 4 |
| Intestinal obstruction | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Nausea | 1/12 (8.3%) | 1 | 3/46 (6.5%) | 4 |
| Vomiting | 0/12 (0%) | 0 | 5/46 (10.9%) | 8 |
| General disorders | ||||
| Fatigue | 2/12 (16.7%) | 2 | 3/46 (6.5%) | 3 |
| Injection site bruising | 5/12 (41.7%) | 16 | 6/46 (13%) | 10 |
| Injection site discolouration | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Injection site erythema | 2/12 (16.7%) | 7 | 0/46 (0%) | 0 |
| Injection site haemorrhage | 0/12 (0%) | 0 | 7/46 (15.2%) | 10 |
| Injection site induration | 1/12 (8.3%) | 3 | 0/46 (0%) | 0 |
| Injection site mass | 1/12 (8.3%) | 2 | 2/46 (4.3%) | 5 |
| Injection site pain | 2/12 (16.7%) | 11 | 4/46 (8.7%) | 5 |
| Injection site pruritus | 1/12 (8.3%) | 19 | 0/46 (0%) | 0 |
| Injection site swelling | 1/12 (8.3%) | 19 | 1/46 (2.2%) | 1 |
| Injection site urticaria | 1/12 (8.3%) | 8 | 0/46 (0%) | 0 |
| Pain | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Immune system disorders | ||||
| Allergy to chemicals | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Seasonal allergy | 0/12 (0%) | 0 | 3/46 (6.5%) | 4 |
| Infections and infestations | ||||
| Bronchitis | 2/12 (16.7%) | 2 | 10/46 (21.7%) | 11 |
| Chronic sinusitis | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Conjunctivitis | 0/12 (0%) | 0 | 3/46 (6.5%) | 5 |
| Ear infection | 2/12 (16.7%) | 2 | 1/46 (2.2%) | 1 |
| Gastroenteritis | 1/12 (8.3%) | 1 | 5/46 (10.9%) | 5 |
| Gastroenteritis viral | 0/12 (0%) | 0 | 3/46 (6.5%) | 4 |
| Influenza | 2/12 (16.7%) | 2 | 5/46 (10.9%) | 5 |
| Localised infection | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Lower respiratory tract infection | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Nasopharyngitis | 2/12 (16.7%) | 3 | 11/46 (23.9%) | 21 |
| Onychomycosis | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Pharyngitis | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Sinusitis | 1/12 (8.3%) | 1 | 5/46 (10.9%) | 6 |
| Tooth infection | 0/12 (0%) | 0 | 3/46 (6.5%) | 4 |
| Upper respiratory tract infection | 4/12 (33.3%) | 9 | 13/46 (28.3%) | 22 |
| Urinary tract infection | 2/12 (16.7%) | 3 | 5/46 (10.9%) | 7 |
| Viral upper respiratory tract infection | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Accidental overdose | 1/12 (8.3%) | 2 | 0/46 (0%) | 0 |
| Contusion | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Epicondylitis | 2/12 (16.7%) | 2 | 0/46 (0%) | 0 |
| Ligament sprain | 1/12 (8.3%) | 1 | 5/46 (10.9%) | 5 |
| Muscle contusion | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Muscle injury | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Muscle strain | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Nasal injury | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Procedural pain | 0/12 (0%) | 0 | 3/46 (6.5%) | 3 |
| Investigations | ||||
| C-Reactive protein increased | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| International normalised ratio increased | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Glucose tolerance impaired | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Gout | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Impaired fasting glucose | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Ketoacidosis | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Vitamin D deficiency | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/12 (25%) | 8 | 8/46 (17.4%) | 15 |
| Back pain | 0/12 (0%) | 0 | 9/46 (19.6%) | 12 |
| Dupuytren's contracture | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Musculoskeletal pain | 0/12 (0%) | 0 | 3/46 (6.5%) | 4 |
| Myalgia | 1/12 (8.3%) | 1 | 8/46 (17.4%) | 13 |
| Neck pain | 0/12 (0%) | 0 | 3/46 (6.5%) | 3 |
| Osteoarthritis | 0/12 (0%) | 0 | 4/46 (8.7%) | 4 |
| Pain in extremity | 2/12 (16.7%) | 3 | 4/46 (8.7%) | 5 |
| Rheumatoid arthritis | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Tendonitis | 1/12 (8.3%) | 1 | 3/46 (6.5%) | 3 |
| Nervous system disorders | ||||
| Amnesia | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Carpal tunnel syndrome | 1/12 (8.3%) | 1 | 2/46 (4.3%) | 2 |
| Cervical radiculopathy | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Dizziness | 1/12 (8.3%) | 2 | 6/46 (13%) | 7 |
| Headache | 1/12 (8.3%) | 1 | 10/46 (21.7%) | 12 |
| Hyperaesthesia | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Hypersomnia | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Hypoaesthesia | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Migraine | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Neuralgia | 1/12 (8.3%) | 2 | 0/46 (0%) | 0 |
| Paraesthesia | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 2 |
| Restless legs syndrome | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Sciatica | 1/12 (8.3%) | 1 | 2/46 (4.3%) | 2 |
| Psychiatric disorders | ||||
| Anxiety | 0/12 (0%) | 0 | 5/46 (10.9%) | 6 |
| Depression | 0/12 (0%) | 0 | 3/46 (6.5%) | 3 |
| Sleep disorder | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Renal and urinary disorders | ||||
| Proteinuria | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 2/12 (16.7%) | 2 | 5/46 (10.9%) | 5 |
| Dyspnoea exertional | 1/12 (8.3%) | 1 | 1/46 (2.2%) | 1 |
| Nasal congestion | 1/12 (8.3%) | 1 | 2/46 (4.3%) | 3 |
| Nasal septum deviation | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Nasal turbinate hypertrophy | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Oropharyngeal pain | 1/12 (8.3%) | 1 | 3/46 (6.5%) | 3 |
| Sleep apnoea syndrome | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Tonsillar hypertrophy | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Wheezing | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Dermal cyst | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Dermatitis contact | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Erythema | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Rash erythematous | 1/12 (8.3%) | 1 | 0/46 (0%) | 0 |
| Urticaria | 1/12 (8.3%) | 1 | 3/46 (6.5%) | 4 |
| Vascular disorders | ||||
| Hypertension | 0/12 (0%) | 0 | 5/46 (10.9%) | 5 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
| Name/Title | Clinical Trial Administrator |
|---|---|
| Organization | Regeneron Pharmaceuticals, Inc. |
| Phone | 844-734-6643 |
| clinicaltrials@regeneron.com |
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01576484
Other Study ID Numbers:
- R727-CL-1032
First Posted:
Apr 12, 2012
Last Update Posted:
Aug 5, 2020
Last Verified:
Jul 1, 2020