Trial · NCT03694197
Long Term Safety Study of PRALUENT
NCT03694197, Phase 4, Terminated, Regeneron Pharmaceuticals; results first posted 2021-06-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Long Term Safety Study of PRALUENT. Trials, record NCT03694197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03694197
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety Study of PRALUENT
- NCT number
- NCT03694197
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 1,389 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
- Interventions
- Praluent
- First posted
- 2018-10-03
- Last updated
- 2021-06-15
- Other registries' IDs
- eudract:2018-002810-11
- Results first posted
- 2021-06-15
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks | An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (\<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities \[MedDRA\] Query \[CMQ\] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications. |
| Secondary | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Secondary | Percent Change in LDL-C From Baseline Over Time | Up to week 72 | |
| Secondary | Total Cholesterol (Total-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Secondary | Percent Change From Baseline in Total-C Over Time | Up to week 72 | |
| Secondary | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Secondary | Percent Change From Baseline in Lp(a) Over Time | Up to week 72 | |
| Secondary | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Secondary | Percent Change From Baseline in Non-HDL-C Over Time | Up to week 72 | |
| Secondary | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks | Safety analysis set (SAF): All participants who received any study drug | Participants | NUMBER |
| SECONDARY | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | Milligrams per decilitre (mg/dL) | MEAN |
| SECONDARY | Percent Change in LDL-C From Baseline Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | Percent Change | MEAN |
| SECONDARY | Total Cholesterol (Total-C) Values From Baseline Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change From Baseline in Total-C Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | Percent Change | MEAN |
| SECONDARY | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change From Baseline in Lp(a) Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | Percent Change | MEAN |
| SECONDARY | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | Percent Change | MEAN |
| SECONDARY | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Up to week 72 | SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint | mg/dL | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group213
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any treatment emergent adverse event (TEAE) | 568 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any treatment emergent serious adverse event (SAE) | 89 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any TEAE leading to death | 5 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any TEAE leading to permanent treatment discontinuation | 9 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any neurocognitive disorders TEAE (by Sponsor CMQ) | 4 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any neurocognitive disorders TEAE (by FDA CMQ) | 0 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any NOD; # analyzed = # of participants w/out diabetes at baseline | 15 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any hepatic disorders TEAE | 14 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any neurological TEAE | 15 | Participants | |
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Alirocumab 75 Q2W/Up150 Q2W | Any general allergic TEAE | 25 | Participants |
1 to 10 of 213Source ClinicalTrials.gov
See all 213 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alirocumab 75 Q2W/Up150 Q2W | 1,385 | |
| Overall Study | COMPLETED | Alirocumab 75 Q2W/Up150 Q2W | 0 | |
| Overall Study | NOT COMPLETED | Alirocumab 75 Q2W/Up150 Q2W | 1,385 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Angina unstable | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 10 | 1,385 | 10 |
| serious | Angina pectoris | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 8 | 1,385 | 8 |
| serious | Atrial fibrillation | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 6 | 1,385 | 6 |
| serious | Acute myocardial infarction | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 5 | 1,385 | 5 |
| serious | Acute left ventricular failure | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 2 | 1,385 | 2 |
| serious | Cardiac failure congestive | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 2 | 1,385 | 2 |
| serious | Coronary artery disease | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 2 | 1,385 | 2 |
| serious | Arrhythmia | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 1 | 1,385 | 1 |
| serious | Cardiac failure | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 1 | 1,385 | 1 |
| serious | Cardiac failure acute | Cardiac disorders | Alirocumab 75 Q2W/Up150 Q2W | 1 | 1,385 | 1 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alirocumab 75 Q2W/Up150 Q2W | 5 | 1,385 |
| Total, other adverse events | Alirocumab 75 Q2W/Up150 Q2W | 0 | 1,385 |
| Total, serious adverse events | Alirocumab 75 Q2W/Up150 Q2W | 89 | 1,385 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03694197
GET https://conductscience.org/api/trials/v1/NCT03694197/registered?page=2