Trial · NCT01439880
Open Label Study of Long Term Evaluation Against LDL-C Trial
NCT01439880, Phase 2, Completed, Amgen; results first posted 2019-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Study of Long Term Evaluation Against LDL-C Trial. Trials, record NCT01439880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01439880
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Study of Long Term Evaluation Against LDL-C Trial
- NCT number
- NCT01439880
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,324 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hypercholesterolemia
- Interventions
- Evolocumab, Standard of care
- First posted
- 2011-09-23
- Last updated
- 2022-09-21
- Other registries' IDs
- eudract:2011-001915-29
- Results first posted
- 2019-07-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months. | Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE. |
| Secondary | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | |
| Secondary | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | |
| Secondary | Apolipoprotein B Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | |
| Secondary | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | |
| Secondary | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 |
Source ClinicalTrials.gov
Outcomes6
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 | 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months. | All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-5). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | Participants randomized in study 20110110 and with available data at each time point. | mg/dL | MEAN |
| SECONDARY | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | Participants randomized in the extension study 20110110 and with available data at each time point. | mg/dL | MEAN |
| SECONDARY | Apolipoprotein B Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | Participants randomized in the extension study 20110110 and with available data at each time point. | mg/dL | MEAN |
| SECONDARY | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | Participants randomized in the extension study 20110110 and with available data at each time point. | ratio | MEAN |
| SECONDARY | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 | Participants randomized in the extension study 20110110 and with available data at each time point. | ratio | MEAN |
Source ClinicalTrials.gov
Results by group114
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 | SOC-controlled Period: Standard of Care | All adverse events | 327 | Participants | |
| Number of Participants With Adverse Events | SOC-controlled Period: Evolocumab + SOC | All adverse events | 728 | Participants | |
| Number of Participants With Adverse Events | All-IP Period: SOC / Evolocumab + SOC | All adverse events | 342 | Participants | |
| Number of Participants With Adverse Events | All-IP Period: Evolocumab + SOC / Evolocumab + SOC | All adverse events | 718 | Participants | |
| Number of Participants With Adverse Events | SOC-controlled Period: Standard of Care | Adverse events ≥ grade 3 | 46 | Participants | |
| Number of Participants With Adverse Events | SOC-controlled Period: Evolocumab + SOC | Adverse events ≥ grade 3 | 99 | Participants | |
| Number of Participants With Adverse Events | All-IP Period: SOC / Evolocumab + SOC | Adverse events ≥ grade 3 | 111 | Participants | |
| Number of Participants With Adverse Events | All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Adverse events ≥ grade 3 | 229 | Participants | |
| Number of Participants With Adverse Events | SOC-controlled Period: Standard of Care | Adverse events ≥ grade 4 | 2 | Participants | |
| Number of Participants With Adverse Events | SOC-controlled Period: Evolocumab + SOC | Adverse events ≥ grade 4 | 11 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| SOC-controlled Period (Year 1) | STARTED | Standard of Care | 442 | |
| SOC-controlled Period (Year 1) | STARTED | Evolocumab + SOC | 882 | |
| SOC-controlled Period (Year 1) | Received Evolocumab | Standard of Care | 0 | |
| SOC-controlled Period (Year 1) | Received Evolocumab | Evolocumab + SOC | 881 | |
| SOC-controlled Period (Year 1) | COMPLETED | Standard of Care | 398 | |
| SOC-controlled Period (Year 1) | COMPLETED | Evolocumab + SOC | 822 | |
| SOC-controlled Period (Year 1) | NOT COMPLETED | Standard of Care | 44 | |
| SOC-controlled Period (Year 1) | NOT COMPLETED | Evolocumab + SOC | 60 | |
| All-IP Period (Years 2 to 5) | STARTED | Standard of Care | 398 | |
| All-IP Period (Years 2 to 5) | STARTED | Evolocumab + SOC | 822 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,840
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 | Diarrhoea | Gastrointestinal disorders | SOC-controlled Period: SOC | 11 | 442 | |
| other | Diarrhoea | Gastrointestinal disorders | SOC-controlled Period: Evolocumab + SOC | 41 | 882 | |
| other | Diarrhoea | Gastrointestinal disorders | All-IP Period: SOC / Evolocumab | 33 | 398 | |
| other | Diarrhoea | Gastrointestinal disorders | All-IP Period: Evolocumab + SOC / Evolocumab | 61 | 822 | |
| other | Diarrhoea | Gastrointestinal disorders | All-IP Period: Total | 94 | 1,220 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | SOC-controlled Period: SOC | 13 | 442 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | SOC-controlled Period: Evolocumab + SOC | 23 | 882 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | All-IP Period: SOC / Evolocumab | 20 | 398 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | All-IP Period: Evolocumab + SOC / Evolocumab | 32 | 822 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | All-IP Period: Total | 52 | 1,220 |
1 to 10 of 1,840Source ClinicalTrials.gov
See all 1,840 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOC-controlled Period: SOC | 2 | 442 |
| Total, all-cause mortality | SOC-controlled Period: Evolocumab + SOC | 1 | 882 |
| Total, all-cause mortality | All-IP Period: SOC / Evolocumab | 3 | 398 |
| Total, all-cause mortality | All-IP Period: Evolocumab + SOC / Evolocumab | 13 | 822 |
| Total, all-cause mortality | All-IP Period: Total | 16 | 1,220 |
| Total, other adverse events | SOC-controlled Period: SOC | 217 | 442 |
| Total, other adverse events | SOC-controlled Period: Evolocumab + SOC | 513 | 882 |
| Total, other adverse events | All-IP Period: SOC / Evolocumab | 311 | 398 |
| Total, other adverse events | All-IP Period: Evolocumab + SOC / Evolocumab | 626 | 822 |
| Total, other adverse events | All-IP Period: Total | 937 | 1,220 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers11
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/NCT01439880
GET https://conductscience.org/api/trials/v1/NCT01439880/results?page=2