Trial · NCT01968967
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
NCT01968967, Phase 3, Completed, Pfizer; results first posted 2017-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events. Trials, record NCT01968967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
- NCT number
- NCT01968967
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,139 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hyperlipidemia
- Interventions
- Bococizumab (PF-04950615; RN316), Placebo
- First posted
- 2013-10-24
- Last updated
- 2018-07-31
- Other registries' IDs
- eudract:2013-002643-28
- Results first posted
- 2017-07-24
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period | Baseline, Week 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
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 Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | A subset of FAS included all participants who were randomized and had TG \<200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | A subset of FAS included all participants who were randomized and had TG \>=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period | Baseline, Week 24, 52 | FAS included all participants who were randomized. Here, N signifies number of participants who were evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points. | percent change | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group161
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 Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Placebo (Treatment Period) | 1.0 | Standard Deviation 22.55 | percent change | |
| Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Bococizumab 150 mg (Treatment Period) | -54.9 | Standard Deviation 26.84 | percent change | |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Placebo (Treatment Period) | Week 12 | -0.1 | Standard Deviation 16.18 | percent change |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Bococizumab 150 mg (Treatment Period) | Week 12 | -34.9 | Standard Deviation 18.34 | percent change |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Placebo (Treatment Period) | Week 24 | 1.0 | Standard Deviation 18.68 | percent change |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Bococizumab 150 mg (Treatment Period) | Week 24 | -30.5 | Standard Deviation 21.56 | percent change |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Placebo (Treatment Period) | Week 52 | -0.3 | Standard Deviation 18.75 | percent change |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 | Bococizumab 150 mg (Treatment Period) | Week 52 | -25.3 | Standard Deviation 23.43 | percent change |
| Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 | Placebo (Treatment Period) | Week 12 | 0.4 | Standard Deviation 18.83 | percent change |
| Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 | Bococizumab 150 mg (Treatment Period) | Week 12 | -50.4 | Standard Deviation 27.42 | percent change |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Placebo (Treatment Period) | 1,071 | |
| Treatment Period | STARTED | Bococizumab 150 mg (Treatment Period) | 1,068 | |
| Treatment Period | STARTED | Placebo (Extension Period) | 0 | |
| Treatment Period | STARTED | Bococizumab ADA Positive (Extension Period) | 0 | |
| Treatment Period | STARTED | Bococizumab ADA Negative (Extension Period) | 0 | |
| Treatment Period | Treated | Placebo (Treatment Period) | 1,065 | |
| Treatment Period | Treated | Bococizumab 150 mg (Treatment Period) | 1,063 | |
| Treatment Period | Treated | Placebo (Extension Period) | 0 | |
| Treatment Period | Treated | Bococizumab ADA Positive (Extension Period) | 0 | |
| Treatment Period | Treated | Bococizumab ADA Negative (Extension Period) | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,140
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 (Treatment Period) | 23 | 1,065 | |
| other | Injection site reaction | General disorders | Bococizumab 150 mg (Treatment Period) | 97 | 1,063 | |
| other | Injection site reaction | General disorders | Placebo (Extension Period) | 0 | 0 | |
| other | Injection site reaction | General disorders | Bococizumab ADA Positive (Extension Period) | 0 | 0 | |
| other | Injection site reaction | General disorders | Bococizumab ADA Negative (Extension Period) | 0 | 0 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (Treatment Period) | 60 | 1,065 | |
| other | Upper respiratory tract infection | Infections and infestations | Bococizumab 150 mg (Treatment Period) | 50 | 1,063 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (Extension Period) | 0 | 0 | |
| other | Upper respiratory tract infection | Infections and infestations | Bococizumab ADA Positive (Extension Period) | 0 | 0 | |
| other | Upper respiratory tract infection | Infections and infestations | Bococizumab ADA Negative (Extension Period) | 0 | 0 |
1 to 10 of 1,140Source ClinicalTrials.gov
See all 1,140 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Treatment Period) | 9 | 1,065 |
| Total, all-cause mortality | Bococizumab 150 mg (Treatment Period) | 2 | 1,063 |
| Total, all-cause mortality | Placebo (Extension Period) | 0 | 47 |
| Total, all-cause mortality | Bococizumab ADA Positive (Extension Period) | 0 | 19 |
| Total, all-cause mortality | Bococizumab ADA Negative (Extension Period) | 0 | 39 |
| Total, other adverse events | Placebo (Treatment Period) | 138 | 1,065 |
| Total, other adverse events | Bococizumab 150 mg (Treatment Period) | 177 | 1,063 |
| Total, other adverse events | Placebo (Extension Period) | 0 | 0 |
| Total, other adverse events | Bococizumab ADA Positive (Extension Period) | 0 | 0 |
| Total, other adverse events | Bococizumab ADA Negative (Extension Period) | 0 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
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 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/NCT01968967
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