Trial · NCT00683618
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
NCT00683618, Phase 3, Completed, AstraZeneca; results first posted 2012-03-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia. Trials, record NCT00683618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00683618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
- NCT number
- NCT00683618
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 934 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hypercholesterolemia
- Interventions
- Rosuvastatin, Atorvastatin
- First posted
- 2008-05-23
- Last updated
- 2012-03-21
- Results first posted
- 2012-03-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population. |
| Primary | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population. |
| Secondary | Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Triglycerides (TG) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Secondary | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | baseline, 6 weeks | percent change | LEAST_SQUARES_MEAN | |
| PRIMARY | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | baseline, 6 weeks | Percent change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Triglycerides (TG) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 | baseline, 6 weeks | Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | Rosuvastatin 5mg | -41.70 | Standard Error 2.62 | percent change | |
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | Atorvastatin 10mg | -38.67 | Standard Error 2.64 | percent change | |
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | Rosuvastatin 10mg | -46.28 | Standard Error 2.62 | Percent change | |
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | Atorvastatin 10mg | -38.67 | Standard Error 2.64 | Percent change | |
| Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | Rosuvastatin 5mg | 5.63 | Standard Error 2.29 | percent change | |
| Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | Rosuvastatin 10mg | 6.82 | Standard Error 2.29 | percent change | |
| Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | Atorvastatin 10mg | 3.64 | Standard Error 2.31 | percent change | |
| Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | Rosuvastatin 5mg | -29.62 | Standard Error 1.92 | percent change | |
| Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | Rosuvastatin 10mg | -33.14 | Standard Error 1.91 | percent change | |
| Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | Atorvastatin 10mg | -28.06 | Standard Error 1.93 | percent change |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomised Treatment Period | STARTED | Rosuvastatin 5mg | 145 | |
| Randomised Treatment Period | STARTED | Rosuvastatin 10mg | 145 | |
| Randomised Treatment Period | STARTED | Atorvastatin 10mg | 146 | |
| Randomised Treatment Period | COMPLETED | Rosuvastatin 5mg | 139 | |
| Randomised Treatment Period | COMPLETED | Rosuvastatin 10mg | 143 | |
| Randomised Treatment Period | COMPLETED | Atorvastatin 10mg | 140 | |
| Randomised Treatment Period | NOT COMPLETED | Rosuvastatin 5mg | 6 | |
| Randomised Treatment Period | NOT COMPLETED | Rosuvastatin 10mg | 2 | |
| Randomised Treatment Period | NOT COMPLETED | Atorvastatin 10mg | 6 | |
| Extension Treatment Period | STARTED | Rosuvastatin 5mg | 36 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events15
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 | Alanine Aminotransferase | Investigations | Rosuvastatin 5mg | 2 | 145 | |
| other | Alanine Aminotransferase | Investigations | Rosuvastatin 10mg | 0 | 145 | |
| other | Alanine Aminotransferase | Investigations | Atorvastatin 10mg | 0 | 146 | |
| other | Blood Creatine Phosphokinase Increased | Investigations | Rosuvastatin 5mg | 2 | 145 | |
| other | Blood Creatine Phosphokinase Increased | Investigations | Rosuvastatin 10mg | 3 | 145 | |
| other | Blood Creatine Phosphokinase Increased | Investigations | Atorvastatin 10mg | 0 | 146 | |
| other | Myalgia | Renal and urinary disorders | Rosuvastatin 5mg | 1 | 145 | |
| other | Myalgia | Renal and urinary disorders | Rosuvastatin 10mg | 0 | 145 | |
| other | Myalgia | Renal and urinary disorders | Atorvastatin 10mg | 0 | 146 | |
| serious | Foot Fracture | Injury, poisoning and procedural complications | Rosuvastatin 5mg | 1 | 145 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin 5mg | ||
| Total, all-cause mortality | Rosuvastatin 10mg | ||
| Total, all-cause mortality | Atorvastatin 10mg | ||
| Total, other adverse events | Rosuvastatin 5mg | 5 | 145 |
| Total, other adverse events | Rosuvastatin 10mg | 3 | 145 |
| Total, other adverse events | Atorvastatin 10mg | 0 | 146 |
| Total, serious adverse events | Rosuvastatin 5mg | 1 | 145 |
| Total, serious adverse events | Rosuvastatin 10mg | 0 | 145 |
| Total, serious adverse events | Atorvastatin 10mg | 1 | 146 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28836458 | 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 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/NCT00683618
GET https://conductscience.org/api/trials/v1/NCT00683618/results?page=2