Trial · NCT01968980
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
NCT01968980, Phase 3, Completed, Pfizer; results first posted 2017-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia. Trials, record NCT01968980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968980
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
- NCT number
- NCT01968980
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 370 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Heterozygous Familial Hypercholesterolemia
- Interventions
- Bococizumab (PF-04950615;RN316), Placebo
- First posted
- 2013-10-24
- Last updated
- 2017-06-26
- Other registries' IDs
- eudract:2013-002644-87
- Results first posted
- 2017-05-19
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Baseline, Week 24, 52 | |
| Secondary | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Baseline, Week 24, 52 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Lipoprotein (a) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Baseline, Week 24, 52 | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Baseline, Week 24, 52 | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | percent change | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Placebo | -0.3 | Standard Deviation 18.30 | percent change | |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | PF--04950615 | -54.2 | Standard Deviation 29.34 | percent change | |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | Placebo | -0.0 | Standard Deviation 14.45 | percent change | |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | PF--04950615 | -37.0 | Standard Deviation 19.82 | percent change | |
| Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Placebo | 0.4 | Standard Deviation 17.89 | percent change | |
| Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | PF--04950615 | -49.9 | Standard Deviation 26.80 | percent change | |
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Placebo | 0.4 | Standard Deviation 15.96 | percent change | |
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | PF--04950615 | -47.5 | Standard Deviation 28.89 | percent change | |
| Percent Change From Baseline in Lipoprotein (a) at Week 12 | Placebo | 2.2 | Standard Deviation 27.21 | percent change | |
| Percent Change From Baseline in Lipoprotein (a) at Week 12 | PF--04950615 | -26.4 | Standard Deviation 23.63 | percent change |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 185 | |
| Overall Study | STARTED | PF--04950615 | 185 | |
| Overall Study | COMPLETED | Placebo | 169 | |
| Overall Study | COMPLETED | PF--04950615 | 171 | |
| Overall Study | NOT COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | PF--04950615 | 14 |
Source ClinicalTrials.gov
Adverse events122
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 |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | Placebo | 1 | 185 | |
| other | Injection site reaction | General disorders | PF--04950615 | 38 | 185 | |
| other | Influenza | Infections and infestations | Placebo | 6 | 185 | |
| other | Influenza | Infections and infestations | PF--04950615 | 10 | 185 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 15 | 185 | |
| other | Nasopharyngitis | Infections and infestations | PF--04950615 | 15 | 185 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 7 | 185 | |
| other | Upper respiratory tract infection | Infections and infestations | PF--04950615 | 11 | 185 | |
| other | Headache | Nervous system disorders | Placebo | 10 | 185 | |
| other | Headache | Nervous system disorders | PF--04950615 | 10 | 185 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PF--04950615 | ||
| Total, other adverse events | Placebo | 36 | 185 |
| Total, other adverse events | PF--04950615 | 70 | 185 |
| Total, serious adverse events | Placebo | 22 | 185 |
| Total, serious adverse events | PF--04950615 | 24 | 185 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PF--04950615 vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01968980
GET https://conductscience.org/api/trials/v1/NCT01968980/registered?page=2