Trial · NCT00639158
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
NCT00639158, Phase 3, Completed, Abbott; results first posted 2009-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood. Trials, record NCT00639158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00639158
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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-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
- NCT number
- NCT00639158
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 543 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia
- Interventions
- ABT-335, placebo, atorvastatin, ezetimibe
- First posted
- 2008-03-20
- Last updated
- 2011-06-13
- Results first posted
- 2009-11-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Percent Change in Triglycerides From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | \[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100 |
| Primary | Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | \[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100 |
| Secondary | Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | \[(Week 12 apoAI minus baseline apoAI)/baseline apoAI\] x 100 |
| Secondary | Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit | Baseline to 12 weeks (final visit) | \[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\] x 100 |
| Secondary | Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | \[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII\] x 100 |
| Secondary | Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | \[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C\] x 100 |
| Secondary | Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | \[(Week 12 apoB minus baseline apoB)/baseline apoB\] x 100 |
| Secondary | Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | \[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP\] x 100 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Percent Change in Triglycerides From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward. | Percent change | MEDIAN |
| SECONDARY | Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward. | Percent change | MEAN |
| PRIMARY | Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward. | Percent change | MEAN |
| SECONDARY | Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit | Baseline to 12 weeks (final visit) | All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, last observation carried forward. | Percent change | MEAN |
| SECONDARY | Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward. | Percent change | MEAN |
| SECONDARY | Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, last observation carried forward. | Percent change | MEAN |
| SECONDARY | Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | All randomized subjects with a baseline apoB value and at least 1 postbaseline apoB value, last observation carried forward. | Percent change | MEAN |
| SECONDARY | Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit | Baseline to 12 weeks (Final Visit) | All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, last observation carried forward. | Percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Percent Change in Triglycerides From Baseline to Final Visit | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | -57.3 | Inter-Quartile Range 22.32 | Percent change | |
| Median Percent Change in Triglycerides From Baseline to Final Visit | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | -39.7 | Inter-Quartile Range 29.44 | Percent change | |
| Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 1.8 | Standard Error 0.74 | Percent change | |
| Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | -1.3 | Standard Error 0.76 | Percent change | |
| Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 13.0 | Standard Error 0.95 | Percent change | |
| Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 4.2 | Standard Error 0.95 | Percent change | |
| Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | -57.8 | Standard Error 1.87 | Percent change | |
| Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | -41.1 | Standard Error 1.87 | Percent change | |
| Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | -42.5 | Standard Error 1.22 | Percent change | |
| Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | -25.3 | Standard Error 1.23 | Percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 272 | |
| Overall Study | STARTED | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 270 | |
| Overall Study | COMPLETED | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 246 | |
| Overall Study | COMPLETED | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 240 | |
| Overall Study | NOT COMPLETED | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 26 | |
| Overall Study | NOT COMPLETED | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 30 |
Source ClinicalTrials.gov
Adverse events36
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 | Arthralgia | Musculoskeletal and connective tissue disorders | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 6 | 272 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 10 | 270 | |
| other | Diarrhea | Gastrointestinal disorders | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 9 | 272 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 6 | 270 | |
| other | Fatigue | General disorders | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 6 | 272 | |
| other | Fatigue | General disorders | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 10 | 270 | |
| other | Headache | Nervous system disorders | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 6 | 272 | |
| other | Headache | Nervous system disorders | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 9 | 270 | |
| other | Muscle Spasms | Musculoskeletal and connective tissue disorders | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 10 | 272 | |
| other | Muscle Spasms | Musculoskeletal and connective tissue disorders | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 9 | 270 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | ||
| Total, all-cause mortality | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | ||
| Total, other adverse events | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 41 | 272 |
| Total, other adverse events | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 51 | 270 |
| Total, serious adverse events | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 3 | 272 |
| Total, serious adverse events | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 5 | 270 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20934572 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe vs Placebo + 40 mg Atorvastatin + 10 mg 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/NCT00639158
GET https://conductscience.org/api/trials/v1/NCT00639158/events?page=2