Trial · NCT01953328
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
NCT01953328, Phase 3, Completed, Amgen; results first posted 2015-12-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk. Trials, record NCT01953328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01953328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
- NCT number
- NCT01953328
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 409 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
- Interventions
- Atorvastatin, Evolocumab, Placebo to Evolocumab
- First posted
- 2013-09-30
- Last updated
- 2015-12-23
- Results first posted
- 2015-12-23
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 Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | |
| Secondary | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and Week 12 |
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 Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | Full analysis set | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group192
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 the Mean of Weeks 10 and 12 | A5 Placebo Q2W | 0.27 | Standard Error 2.21 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A5 Placebo QM | 3.91 | Standard Error 2.09 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A5 Evolocumab Q2W | -73.70 | Standard Error 2.26 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A5 Evolocumab QM | -69.98 | Standard Error 2.02 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A20 Placebo Q2W | -0.42 | Standard Error 3.26 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A20 Placebo QM | -2.67 | Standard Error 2.31 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A20 Evolocumab Q2W | -74.82 | Standard Error 3.26 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | A20 Evolocumab QM | -76.93 | Standard Error 2.24 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A5 Placebo Q2W | 1.28 | Standard Error 2.43 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A5 Placebo QM | 5.29 | Standard Error 2.19 | percent change |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A5 Placebo Q2W | 49 | |
| Overall Study | STARTED | A5 Placebo QM | 50 | |
| Overall Study | STARTED | A5 Evolocumab Q2W | 50 | |
| Overall Study | STARTED | A5 Evolocumab QM | 50 | |
| Overall Study | STARTED | A20 Placebo Q2W | 52 | |
| Overall Study | STARTED | A20 Placebo QM | 51 | |
| Overall Study | STARTED | A20 Evolocumab Q2W | 51 | |
| Overall Study | STARTED | A20 Evolocumab QM | 51 | |
| Overall Study | Received Treatment | A5 Placebo Q2W | 49 | |
| Overall Study | Received Treatment | A5 Placebo QM | 50 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events72
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 | Gastroenteritis | Infections and infestations | A5 Placebo Q2W | 1 | 49 | |
| other | Gastroenteritis | Infections and infestations | A5 Placebo QM | 0 | 50 | |
| other | Gastroenteritis | Infections and infestations | A5 Evolocumab Q2W | 1 | 50 | |
| other | Gastroenteritis | Infections and infestations | A5 Evolocumab QM | 2 | 50 | |
| other | Gastroenteritis | Infections and infestations | A20 Placebo Q2W | 1 | 52 | |
| other | Gastroenteritis | Infections and infestations | A20 Placebo QM | 0 | 51 | |
| other | Gastroenteritis | Infections and infestations | A20 Evolocumab Q2W | 0 | 51 | |
| other | Gastroenteritis | Infections and infestations | A20 Evolocumab QM | 3 | 51 | |
| other | Nasopharyngitis | Infections and infestations | A5 Placebo Q2W | 10 | 49 | |
| other | Nasopharyngitis | Infections and infestations | A5 Placebo QM | 10 | 50 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A5 Placebo Q2W | ||
| Total, all-cause mortality | A5 Placebo QM | ||
| Total, all-cause mortality | A5 Evolocumab Q2W | ||
| Total, all-cause mortality | A5 Evolocumab QM | ||
| Total, all-cause mortality | A20 Placebo Q2W | ||
| Total, all-cause mortality | A20 Placebo QM | ||
| Total, all-cause mortality | A20 Evolocumab Q2W | ||
| Total, all-cause mortality | A20 Evolocumab QM | ||
| Total, other adverse events | A5 Placebo Q2W | 11 | 49 |
| Total, other adverse events | A5 Placebo QM | 11 | 50 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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/NCT01953328
GET https://conductscience.org/api/trials/v1/NCT01953328/registered?page=2