Trial · NCT00463606
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
NCT00463606, Phase 3, Completed, AstraZeneca; results first posted 2012-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia. Trials, record NCT00463606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00463606
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
- NCT number
- NCT00463606
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 760 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Interventions
- ABT-335 and rosuvastatin calcium, ABT-335, rosuvastatin calcium
- First posted
- 2007-04-20
- Last updated
- 2012-10-03
- Results first posted
- 2012-08-01
Source ClinicalTrials.gov
Registered outcomes9
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 High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
| Primary | Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
| Primary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
| Secondary | Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) | Baseline to 12 Weeks | The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) | Baseline to 12 Weeks | The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. |
Source ClinicalTrials.gov
Outcomes9
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 High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. 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 |
| PRIMARY | Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was 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 | MEAN |
| PRIMARY | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. 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 Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-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 |
| SECONDARY | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-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 |
| SECONDARY | Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-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 Apolipoprotein B (ApoB) (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. 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 | Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. 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 |
| SECONDARY | Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) | Baseline to 12 Weeks | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. 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 group18
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 High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) | ABT-335 and Rosuvastatin Calcium | 23.0 | Standard Error 1.33 | percent change | |
| Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) | Rosuvastatin Calcium | 12.4 | Standard Error 1.32 | percent change | |
| Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) | ABT-335 and Rosuvastatin Calcium | -40.3 | Standard Error 1.89 | percent change | |
| Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) | Rosuvastatin Calcium | -17.5 | Standard Error 1.88 | percent change | |
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | ABT-335 and Rosuvastatin Calcium | -28.7 | Standard Error 1.33 | percent change | |
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | ABT-335 | -4.1 | Standard Error 1.31 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) | ABT-335 and Rosuvastatin Calcium | -37.4 | Standard Error 1.06 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) | ABT-335 | -16.0 | Standard Error 1.05 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) | ABT-335 and Rosuvastatin Calcium | -37.4 | Standard Error 1.06 | percent change | |
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) | Rosuvastatin Calcium | -31.8 | Standard Error 1.05 | percent change |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 and Rosuvastatin Calcium | 253 | |
| Overall Study | STARTED | ABT-335 | 254 | |
| Overall Study | STARTED | Rosuvastatin Calcium | 251 | |
| Overall Study | COMPLETED | ABT-335 and Rosuvastatin Calcium | 212 | |
| Overall Study | COMPLETED | ABT-335 | 220 | |
| Overall Study | COMPLETED | Rosuvastatin Calcium | 231 | |
| Overall Study | NOT COMPLETED | ABT-335 and Rosuvastatin Calcium | 41 | |
| Overall Study | NOT COMPLETED | ABT-335 | 34 | |
| Overall Study | NOT COMPLETED | Rosuvastatin Calcium | 20 |
Source ClinicalTrials.gov
Adverse 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 | Dyspepsia | Gastrointestinal disorders | ABT-335 and Rosuvastatin Calcium | 16 | 253 | |
| other | Dyspepsia | Gastrointestinal disorders | ABT-335 | 6 | 254 | |
| other | Dyspepsia | Gastrointestinal disorders | Rosuvastatin Calcium | 2 | 251 | |
| other | Nasopharyngitis | Infections and infestations | ABT-335 and Rosuvastatin Calcium | 6 | 253 | |
| other | Nasopharyngitis | Infections and infestations | ABT-335 | 15 | 254 | |
| other | Nasopharyngitis | Infections and infestations | Rosuvastatin Calcium | 8 | 251 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | ABT-335 and Rosuvastatin Calcium | 11 | 253 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | ABT-335 | 11 | 254 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Rosuvastatin Calcium | 14 | 251 | |
| other | Headache | Nervous system disorders | ABT-335 and Rosuvastatin Calcium | 28 | 253 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABT-335 and Rosuvastatin Calcium | ||
| Total, all-cause mortality | ABT-335 | ||
| Total, all-cause mortality | Rosuvastatin Calcium | ||
| Total, other adverse events | ABT-335 and Rosuvastatin Calcium | 52 | 253 |
| Total, other adverse events | ABT-335 | 41 | 254 |
| Total, other adverse events | Rosuvastatin Calcium | 45 | 251 |
| Total, serious adverse events | ABT-335 and Rosuvastatin Calcium | 7 | 253 |
| Total, serious adverse events | ABT-335 | 6 | 254 |
| Total, serious adverse events | Rosuvastatin Calcium | 4 | 251 |
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/NCT00463606
GET https://conductscience.org/api/trials/v1/NCT00463606/events?page=2