Trial · NCT01984424
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
NCT01984424, Phase 3, Completed, Amgen; results first posted 2018-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3. Trials, record NCT01984424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01984424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
- NCT number
- NCT01984424
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 511 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hyperlipidemia
- Interventions
- Atorvastatin, Placebo to Atorvastatin, Placebo to Ezetimibe, Ezetimibe, Placebo to Evolocumab, Evolocumab
- First posted
- 2013-11-14
- Last updated
- 2018-11-29
- Other registries' IDs
- eudract:2013-000935-29
- Results first posted
- 2018-03-13
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 | Baseline and weeks 22 and 24 | |
| Primary | Percent Change From Baseline in LDL-C at Week 24 | Baseline and week 24 | |
| Secondary | Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 | Baselie and weeks 22 and 24 | |
| Secondary | Change From Baseline in LDL-C at Week 24 | Baseline and week 24 | |
| Secondary | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL | Weeks 22 and 24 | |
| Secondary | Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL | Week 24 | |
| Secondary | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24 | Baseline and weeks 22 and 24 | |
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 24 | Baseline and week 24 | |
| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24 | Baseline and weeks 22 and 24 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 | Baseline and week 24 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 LDL-C at the Mean of Weeks 22 and 24 | Baseline and weeks 22 and 24 | Participants randomized and dosed in part B of the study | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline in LDL-C at Week 24 | Baseline and week 24 | Participants randomized and dosed in part B of the study | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 | Baselie and weeks 22 and 24 | Participants randomized and dosed in Part B of the study | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at Week 24 | Baseline and week 24 | Participants randomized and dosed in Part B of the study | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL | Weeks 22 and 24 | Participants randomized and dosed in Part B of the study | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL | Week 24 | Participants randomized and dosed in Part B of the study | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24 | Baseline and weeks 22 and 24 | Participants randomized and dosed in Part B of the study | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol at Week 24 | Baseline and week 24 | Participants randomized and dosed in Part B of the study | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24 | Baseline and weeks 22 and 24 | Participants randomized and dosed in Part B of the study | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 24 | Baseline and week 24 | Participants randomized and dosed in Part B of the study | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group48
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 LDL-C at the Mean of Weeks 22 and 24 | Ezetimibe | -16.70 | Standard Error 1.91 | percent change | |
| Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 | Evolocumab | -54.50 | Standard Error 1.39 | percent change | |
| Percent Change From Baseline in LDL-C at Week 24 | Ezetimibe | -16.69 | Standard Error 2.11 | percent change | |
| Percent Change From Baseline in LDL-C at Week 24 | Evolocumab | -52.76 | Standard Error 1.52 | percent change | |
| Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 | Ezetimibe | -31.0 | Standard Error 3.8 | mg/dL | |
| Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 | Evolocumab | -106.8 | Standard Error 2.7 | mg/dL | |
| Change From Baseline in LDL-C at Week 24 | Ezetimibe | -31.2 | Standard Error 4.0 | mg/dL | |
| Change From Baseline in LDL-C at Week 24 | Evolocumab | -102.9 | Standard Error 2.9 | mg/dL | |
| Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL | Ezetimibe | 1.4 | 95% Confidence Interval 0.3 to 7.7 | percentage of participants | |
| Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL | Evolocumab | 29.9 | 95% Confidence Interval 22.9 to 38.1 | percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe | 73 | |
| Overall Study | STARTED | Evolocumab | 145 | |
| Overall Study | COMPLETED | Ezetimibe | 70 | |
| Overall Study | COMPLETED | Evolocumab | 138 | |
| Overall Study | NOT COMPLETED | Ezetimibe | 3 | |
| Overall Study | NOT COMPLETED | Evolocumab | 7 |
Source ClinicalTrials.gov
Adverse events64
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 | Constipation | Gastrointestinal disorders | Evolocumab | 3 | 145 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe | 4 | 73 | |
| other | Diarrhoea | Gastrointestinal disorders | Evolocumab | 6 | 145 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe | 4 | 73 | |
| other | Fatigue | General disorders | Evolocumab | 12 | 145 | |
| other | Fatigue | General disorders | Ezetimibe | 5 | 73 | |
| other | Influenza like illness | General disorders | Evolocumab | 1 | 145 | |
| other | Influenza like illness | General disorders | Ezetimibe | 4 | 73 | |
| other | Bronchitis | Infections and infestations | Evolocumab | 1 | 145 | |
| other | Bronchitis | Infections and infestations | Ezetimibe | 4 | 73 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Evolocumab | ||
| Total, all-cause mortality | Ezetimibe | ||
| Total, other adverse events | Evolocumab | 80 | 145 |
| Total, other adverse events | Ezetimibe | 40 | 73 |
| Total, serious adverse events | Evolocumab | 9 | 145 |
| Total, serious adverse events | Ezetimibe | 10 | 73 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| Evolocumab vs Ezetimibe: 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/NCT01984424
GET https://conductscience.org/api/trials/v1/NCT01984424/registered?page=2