Trial · NCT00812955
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
NCT00812955, Phase 3, Completed, AstraZeneca; results first posted 2012-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides. Trials, record NCT00812955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00812955
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
- NCT number
- NCT00812955
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 474 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
- Interventions
- ABT-143, simvastatin
- First posted
- 2008-12-22
- Last updated
- 2012-10-03
- Results first posted
- 2012-08-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | Baseline to 8 weeks | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | Baseline to 8 weeks | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | Baseline to 8 weeks | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. |
| Other | Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | Baseline to 8 weeks | The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set. |
| Other | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set) | Baseline to 8 weeks | The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | Baseline to 8 weeks | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | percent change | MEAN |
| SECONDARY | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | Baseline to 8 weeks | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | percent change | MEAN |
| SECONDARY | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | Baseline to 8 weeks | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | percent change | MEAN |
| OTHER_PRE_SPECIFIED | Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | Baseline to 8 weeks | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | percent change | MEDIAN |
| OTHER_PRE_SPECIFIED | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set) | Baseline to 8 weeks | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | Simvastatin Capsules 40 mg | -32.8 | Standard Error 1.59 | percent change | |
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | ABT-143 Capsules 20/135 mg | -47.2 | Standard Error 1.60 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | Simvastatin Capsules 40 mg | -32.8 | Standard Error 1.59 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | ABT-143 Capsules 10/135 mg | -46.0 | Standard Error 1.59 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | Simvastatin Capsules 40 mg | -32.8 | Standard Error 1.59 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | ABT-143 Capsules 5/135 mg | -38.9 | Standard Error 1.59 | percent change | |
| Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | Simvastatin Capsules 40 mg | -20.8 | Inter-Quartile Range -41.3 to 1.9 | percent change | |
| Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | ABT-143 Capsules 5/135 mg | -42.7 | Inter-Quartile Range -54.5 to -30.4 | percent change | |
| Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | ABT-143 Capsules 10/135 mg | -44.6 | Inter-Quartile Range -55.4 to -31.6 | percent change | |
| Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | ABT-143 Capsules 20/135 mg | -50.0 | Inter-Quartile Range -57.5 to -32.1 | percent change |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Simvastatin Capsules 40 mg | 119 | |
| Overall Study | STARTED | ABT-143 Capsules 5/135 mg | 118 | |
| Overall Study | STARTED | ABT-143 Capsules 10/135 mg | 119 | |
| Overall Study | STARTED | ABT-143 Capsules 20/135 mg | 118 | |
| Overall Study | COMPLETED | Simvastatin Capsules 40 mg | 109 | |
| Overall Study | COMPLETED | ABT-143 Capsules 5/135 mg | 111 | |
| Overall Study | COMPLETED | ABT-143 Capsules 10/135 mg | 113 | |
| Overall Study | COMPLETED | ABT-143 Capsules 20/135 mg | 110 | |
| Overall Study | NOT COMPLETED | Simvastatin Capsules 40 mg | 10 | |
| Overall Study | NOT COMPLETED | ABT-143 Capsules 5/135 mg | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
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 | Nausea | Gastrointestinal disorders | Simvastatin Capsules 40 mg | 2 | 119 | |
| other | Nausea | Gastrointestinal disorders | ABT-143 Capsules 5/135 mg | 7 | 118 | |
| other | Nausea | Gastrointestinal disorders | ABT-143 Capsules 10/135 mg | 3 | 119 | |
| other | Nausea | Gastrointestinal disorders | ABT-143 Capsules 20/135 mg | 6 | 118 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Simvastatin Capsules 40 mg | 1 | 119 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | ABT-143 Capsules 5/135 mg | 2 | 118 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | ABT-143 Capsules 10/135 mg | 2 | 119 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | ABT-143 Capsules 20/135 mg | 7 | 118 | |
| other | Headache | Nervous system disorders | Simvastatin Capsules 40 mg | 8 | 119 | |
| other | Headache | Nervous system disorders | ABT-143 Capsules 5/135 mg | 5 | 118 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Simvastatin Capsules 40 mg | ||
| Total, all-cause mortality | ABT-143 Capsules 5/135 mg | ||
| Total, all-cause mortality | ABT-143 Capsules 10/135 mg | ||
| Total, all-cause mortality | ABT-143 Capsules 20/135 mg | ||
| Total, other adverse events | Simvastatin Capsules 40 mg | 10 | 119 |
| Total, other adverse events | ABT-143 Capsules 5/135 mg | 13 | 118 |
| Total, other adverse events | ABT-143 Capsules 10/135 mg | 6 | 119 |
| Total, other adverse events | ABT-143 Capsules 20/135 mg | 17 | 118 |
| Total, serious adverse events | Simvastatin Capsules 40 mg | 0 | 119 |
| Total, serious adverse events | ABT-143 Capsules 5/135 mg | 4 | 118 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20524719 | DERIVED |
Source PubMed
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/NCT00812955
GET https://conductscience.org/api/trials/v1/NCT00812955/events?page=2