Trial · NCT00300456
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
NCT00300456, Phase 3, Completed, Abbott; results first posted 2009-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood. Trials, record NCT00300456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00300456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
- NCT number
- NCT00300456
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 657 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Interventions
- ABT-335, Simvastatin, Placebo
- First posted
- 2006-03-09
- Last updated
- 2009-06-03
- Results first posted
- 2009-03-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean 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 |
| Primary | Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | \[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] 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 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 Total Cholesterol From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | \[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol\] x 100 |
| Secondary | Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | \[(Week 12 Apo B minus baseline Apo B)/baseline Apo B\] 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 | Mean 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 | 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 HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward | percent change | MEAN |
| PRIMARY | Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C 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, LOCF | 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, LOCF | percent change | MEAN |
| SECONDARY | Mean Percent Change in Total Cholesterol From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF | percent change | MEAN |
| SECONDARY | Mean Percent Change in Lipoprotein Apo B (Apo B) 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, LOCF | 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, LOCF | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change in Triglycerides From Baseline to Final Visit | ABT-335 + 20 mg Simvastatin | -37.4 | Standard Error 2.75 | percent change | |
| Mean Percent Change in Triglycerides From Baseline to Final Visit | ABT-335 + 40 mg Simvastatin | -42.7 | Standard Error 2.77 | percent change | |
| Mean Percent Change in Triglycerides From Baseline to Final Visit | ABT-335 | -31.7 | Standard Error 2.74 | percent change | |
| Mean Percent Change in Triglycerides From Baseline to Final Visit | 20 mg Simvastatin | -14.2 | Standard Error 2.71 | percent change | |
| Mean Percent Change in Triglycerides From Baseline to Final Visit | 40 mg Simvastatin | -22.4 | Standard Error 2.76 | percent change | |
| Mean Percent Change in Triglycerides From Baseline to Final Visit | 80 mg Simvastatin | -20.2 | Standard Error 3.82 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | ABT-335 + 20 mg Simvastatin | 17.8 | Standard Error 1.86 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | ABT-335 + 40 mg Simvastatin | 18.9 | Standard Error 1.86 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | ABT-335 | 16.2 | Standard Error 1.85 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | 20 mg Simvastatin | 7.2 | Standard Error 1.80 | percent change |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABT-335 + 20 mg Simvastatin | 119 | |
| Overall Study | STARTED | ABT-335 + 40 mg Simvastatin | 118 | |
| Overall Study | STARTED | ABT-335 | 119 | |
| Overall Study | STARTED | 20 mg Simvastatin | 119 | |
| Overall Study | STARTED | 40 mg Simvastatin | 116 | |
| Overall Study | STARTED | 80 mg Simvastatin | 59 | |
| Overall Study | COMPLETED | ABT-335 + 20 mg Simvastatin | 103 | |
| Overall Study | COMPLETED | ABT-335 + 40 mg Simvastatin | 102 | |
| Overall Study | COMPLETED | ABT-335 | 98 | |
| Overall Study | COMPLETED | 20 mg Simvastatin | 105 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events306
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 | Abdominal pain | Gastrointestinal disorders | ABT-335 + 20 mg Simvastatin | 1 | 119 | |
| other | Abdominal pain | Gastrointestinal disorders | ABT-335 + 40 mg Simvastatin | 4 | 118 | |
| other | Abdominal pain | Gastrointestinal disorders | ABT-335 | 3 | 119 | |
| other | Abdominal pain | Gastrointestinal disorders | 20 mg Simvastatin | 1 | 119 | |
| other | Abdominal pain | Gastrointestinal disorders | 40 mg Simvastatin | 1 | 116 | |
| other | Abdominal pain | Gastrointestinal disorders | 80 mg Simvastatin | 0 | 59 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ABT-335 + 20 mg Simvastatin | 4 | 119 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ABT-335 + 40 mg Simvastatin | 2 | 118 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ABT-335 | 3 | 119 | |
| other | Abdominal pain upper | Gastrointestinal disorders | 20 mg Simvastatin | 1 | 119 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABT-335 + 20 mg Simvastatin | ||
| Total, all-cause mortality | ABT-335 + 40 mg Simvastatin | ||
| Total, all-cause mortality | ABT-335 | ||
| Total, all-cause mortality | 20 mg Simvastatin | ||
| Total, all-cause mortality | 40 mg Simvastatin | ||
| Total, all-cause mortality | 80 mg Simvastatin | ||
| Total, other adverse events | ABT-335 + 20 mg Simvastatin | 65 | |
| Total, other adverse events | ABT-335 + 40 mg Simvastatin | 72 | |
| Total, other adverse events | ABT-335 | 67 | |
| Total, other adverse events | 20 mg Simvastatin | 60 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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/NCT00300456
GET https://conductscience.org/api/trials/v1/NCT00300456/results?page=2