Trial · NCT00525824
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
NCT00525824, Phase 3, Completed, AstraZeneca; results first posted 2009-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe. Trials, record NCT00525824. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00525824
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
- NCT number
- NCT00525824
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,743 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
- Interventions
- Rosuvastatin (Crestor), Ezetimibe, Simvastatin
- First posted
- 2007-09-06
- Last updated
- 2011-05-13
- Results first posted
- 2009-10-07
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in TC = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in TG = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in TC/HDL-C After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100 |
| Secondary | Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in TC/HDL-C After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN | |
| SECONDARY | Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment | Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) | Percentage | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment | R10 to R10 + E10 | -59.7200 | Standard Deviation 14.1660 | Percentage | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment | R20 to R20 + E10 | -63.4800 | Standard Deviation 16.6970 | Percentage | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment | S40 to S40 + E10 | -55.2200 | Standard Deviation 15.7500 | Percentage | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment | S80 to S80 + E10 | -57.4200 | Standard Deviation 20.4660 | Percentage | |
| Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment | R10 to R10 + E10 | 6.4100 | Standard Deviation 13.9340 | Percentage | |
| Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment | R20 to R20 + E10 | 7.4600 | Standard Deviation 16.3510 | Percentage | |
| Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment | S40 to S40 + E10 | 3.9200 | Standard Deviation 12.6830 | Percentage | |
| Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment | S80 to S80 + E10 | 4.3400 | Standard Deviation 12.6430 | Percentage | |
| Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment | R10 to R10 + E10 | -43.0000 | Standard Deviation 11.2080 | Percentage | |
| Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment | R20 to R20 + E10 | -46.6300 | Standard Deviation 12.8180 | Percentage |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | R10 to R10 + E10 | 214 | |
| Overall Study | STARTED | R20 to R20 + E10 | 214 | |
| Overall Study | STARTED | S40 to S40 + E10 | 202 | |
| Overall Study | STARTED | S80 to S80 + E10 | 203 | |
| Overall Study | COMPLETED | R10 to R10 + E10 | 195 | |
| Overall Study | COMPLETED | R20 to R20 + E10 | 186 | |
| Overall Study | COMPLETED | S40 to S40 + E10 | 183 | |
| Overall Study | COMPLETED | S80 to S80 + E10 | 188 | |
| Overall Study | NOT COMPLETED | R10 to R10 + E10 | 19 | |
| Overall Study | NOT COMPLETED | R20 to R20 + E10 | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events280
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 | Rosuvastatin 10 mg | 4 | 213 | |
| other | Nausea | Gastrointestinal disorders | Rosuvastatin 20 mg | 5 | 212 | |
| other | Nausea | Gastrointestinal disorders | Simvastatin 40 mg | 1 | 199 | |
| other | Nausea | Gastrointestinal disorders | Simvastatin 80 mg | 1 | 203 | |
| other | Nausea | Gastrointestinal disorders | Rosu 10 mg + Eze 10 mg | 1 | 200 | |
| other | Nausea | Gastrointestinal disorders | Rosu 20 mg + Eze 10 mg | 3 | 191 | |
| other | Nausea | Gastrointestinal disorders | Simva 40 mg + Eze 10 mg | 2 | 189 | |
| other | Nausea | Gastrointestinal disorders | Simva 80 mg + Eze 10 mg | 1 | 192 | |
| other | Oedema peripheral | General disorders | Rosuvastatin 10 mg | 0 | 213 | |
| other | Oedema peripheral | General disorders | Rosuvastatin 20 mg | 0 | 212 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin 10 mg | ||
| Total, all-cause mortality | Rosuvastatin 20 mg | ||
| Total, all-cause mortality | Simvastatin 40 mg | ||
| Total, all-cause mortality | Simvastatin 80 mg | ||
| Total, all-cause mortality | Rosu 10 mg + Eze 10 mg | ||
| Total, all-cause mortality | Rosu 20 mg + Eze 10 mg | ||
| Total, all-cause mortality | Simva 40 mg + Eze 10 mg | ||
| Total, all-cause mortality | Simva 80 mg + Eze 10 mg | ||
| Total, other adverse events | Rosuvastatin 10 mg | 25 | |
| Total, other adverse events | Rosuvastatin 20 mg | 31 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00525824
GET https://conductscience.org/api/trials/v1/NCT00525824/results?page=2