Trial · NCT00300430
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
NCT00300430, Phase 3, Completed, Abbott; results first posted 2009-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. Trials, record NCT00300430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00300430
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
- NCT number
- NCT00300430
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,911 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Interventions
- ABT-335 and rosuvastatin calcium, ABT-335 and atorvastatin calcium, ABT-335 and simvastatin
- First posted
- 2006-03-09
- Last updated
- 2009-07-23
- Results first posted
- 2009-07-23
- Limitations and caveats
- This was an open-label study designed to assess the longer-term safety of the combination therapies. Evaluation of efficacy outcomes was a secondary objective.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study | Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy | |
| Secondary | Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | |
| Secondary | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | |
| Secondary | Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | |
| Secondary | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study | Baseline to Week 52 in this open-label study | |
| Secondary | Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | |
| Secondary | Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | |
| Secondary | Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | |
| Secondary | Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEDIAN |
| SECONDARY | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEAN |
| SECONDARY | Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEAN |
| SECONDARY | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study | Baseline to Week 52 in this open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEAN |
| SECONDARY | Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEAN |
| SECONDARY | Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEAN |
| SECONDARY | Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEAN |
| PRIMARY | Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study | Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized. | percentage of participants | NUMBER |
| SECONDARY | Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study | Baseline to Week 52 of the open-label study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group27
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 Week 52 of the Open-label Study | ABT-335 + 20 mg Rosuvastatin | -53.0 | Full Range 27.67 | percent change | |
| Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study | ABT-335 + 40 mg Simvastatin | -47.7 | Full Range 24.62 | percent change | |
| Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study | ABT-335 + 40 mg Atorvastatin | -56.2 | Full Range 24.56 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study | ABT-335 + 20 mg Rosuvastatin | 25.2 | Standard Deviation 23.22 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study | ABT-335 + 40 mg Simvastatin | 25.1 | Standard Deviation 25.08 | percent change | |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study | ABT-335 + 40 mg Atorvastatin | 19.4 | Standard Deviation 20.58 | percent change | |
| Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study | ABT-335 + 20 mg Rosuvastatin | -41.6 | Standard Deviation 20.77 | percent change | |
| Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study | ABT-335 + 40 mg Simvastatin | -30.2 | Standard Deviation 21.83 | percent change | |
| Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study | ABT-335 + 40 mg Atorvastatin | -38.1 | Standard Deviation 19.09 | percent change | |
| Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study | ABT-335 + 20 mg Rosuvastatin | -48.8 | Standard Deviation 15.80 | percent change |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABT-335 + 20 mg Rosuvastatin | 1,186 | |
| Overall Study | STARTED | ABT-335 + 40 mg Simvastatin | 514 | |
| Overall Study | STARTED | ABT-335 + 40 mg Atorvastatin | 501 | |
| Overall Study | COMPLETED | ABT-335 + 20 mg Rosuvastatin | 819 | |
| Overall Study | COMPLETED | ABT-335 + 40 mg Simvastatin | 345 | |
| Overall Study | COMPLETED | ABT-335 + 40 mg Atorvastatin | 350 | |
| Overall Study | NOT COMPLETED | ABT-335 + 20 mg Rosuvastatin | 367 | |
| Overall Study | NOT COMPLETED | ABT-335 + 40 mg Simvastatin | 169 | |
| Overall Study | NOT COMPLETED | ABT-335 + 40 mg Atorvastatin | 151 |
Source ClinicalTrials.gov
Adverse events471
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 | Diarrhea | Gastrointestinal disorders | ABT-335 + 20 mg Rosuvastatin | 49 | 1,186 | |
| other | Diarrhea | Gastrointestinal disorders | ABT-335 + 40 mg Simvastatin | 26 | 514 | |
| other | Diarrhea | Gastrointestinal disorders | ABT-335 + 40 mg Atorvastatin | 33 | 501 | |
| other | Dyspepsia | Gastrointestinal disorders | ABT-335 + 20 mg Rosuvastatin | 42 | 1,186 | |
| other | Dyspepsia | Gastrointestinal disorders | ABT-335 + 40 mg Simvastatin | 31 | 514 | |
| other | Dyspepsia | Gastrointestinal disorders | ABT-335 + 40 mg Atorvastatin | 28 | 501 | |
| other | Nausea | Gastrointestinal disorders | ABT-335 + 20 mg Rosuvastatin | 61 | 1,186 | |
| other | Nausea | Gastrointestinal disorders | ABT-335 + 40 mg Simvastatin | 23 | 514 | |
| other | Nausea | Gastrointestinal disorders | ABT-335 + 40 mg Atorvastatin | 34 | 501 | |
| other | Bronchitis | Infections and infestations | ABT-335 + 20 mg Rosuvastatin | 60 | 1,186 |
1 to 10 of 471Source ClinicalTrials.gov
See all 471 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABT-335 + 20 mg Rosuvastatin | ||
| Total, all-cause mortality | ABT-335 + 40 mg Simvastatin | ||
| Total, all-cause mortality | ABT-335 + 40 mg Atorvastatin | ||
| Total, other adverse events | ABT-335 + 20 mg Rosuvastatin | 646 | |
| Total, other adverse events | ABT-335 + 40 mg Simvastatin | 308 | |
| Total, other adverse events | ABT-335 + 40 mg Atorvastatin | 283 | |
| Total, serious adverse events | ABT-335 + 20 mg Rosuvastatin | 85 | |
| Total, serious adverse events | ABT-335 + 40 mg Simvastatin | 40 | |
| Total, serious adverse events | ABT-335 + 40 mg Atorvastatin | 23 |
Source ClinicalTrials.gov
Papers2
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/NCT00300430
GET https://conductscience.org/api/trials/v1/NCT00300430/results?page=2