Trial · NCT00631189
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
NCT00631189, Phase 4, Completed, AstraZeneca; results first posted 2010-09-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients. Trials, record NCT00631189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00631189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
- NCT number
- NCT00631189
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 668 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type IIa and IIb Hypercholesterolaemia
- Interventions
- Rosuvastatin, Pravastatin, Atorvastatin
- First posted
- 2008-03-07
- Last updated
- 2013-11-26
- Other registries' IDs
- eudract:2006-006697-15
- Results first posted
- 2010-09-17
- Limitations and caveats
As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | Change from baseline and after 8 weeks of treatment | To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | from baseline and after 8 weeks of treatment | To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | After 8 weeks of treatment | Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks | Baseline and after 8 weeks of treatment | To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment | baseline and after 8 weeks of treatment | To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Percentage of Variation of C-reactive Protein (CRP) | baseline and after 8 weeks of treatment | To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Percentage of Variation of Phospholipase A2 (PLA2) | from baseline and after 8 weeks of treatment | To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
| Secondary | Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients | from baseline and after 8 weeks of treatment | To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | Change from baseline and after 8 weeks of treatment | 92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group | percentage of LDL-C decrease | MEAN |
| SECONDARY | To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done | |||
| SECONDARY | To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done | |||
| SECONDARY | Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | from baseline and after 8 weeks of treatment | percentage of total cholesterol decrease | MEAN | |
| SECONDARY | Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | After 8 weeks of treatment | percentage of HDL-C increase | MEAN | |
| SECONDARY | Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks | Baseline and after 8 weeks of treatment | percentage of triglycerides decrease | MEAN | |
| SECONDARY | Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment | baseline and after 8 weeks of treatment | percent. Apolipoprotein B/A1 decrease | MEAN | |
| SECONDARY | Compare the Percentage of Variation of C-reactive Protein (CRP) | baseline and after 8 weeks of treatment | percent of variation of C-reactive prot. | MEAN | |
| SECONDARY | Compare the Percentage of Variation of Phospholipase A2 (PLA2) | from baseline and after 8 weeks of treatment | percent of variation of phospholipase A2 | MEAN | |
| SECONDARY | Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients | from baseline and after 8 weeks of treatment | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | Atorvastatin | -39.4 | Standard Deviation 13.77 | percentage of LDL-C decrease | |
| Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | Pravastatin | -30.3 | Standard Deviation 15.43 | percentage of LDL-C decrease | |
| Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | Rosuvastatin | -37.6 | Standard Deviation 17.96 | percentage of LDL-C decrease | |
| Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | Atorvastatin | -28.6 | Standard Deviation 11.0 | percentage of total cholesterol decrease | |
| Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | Pravastatin | -20.4 | Standard Deviation 11.7 | percentage of total cholesterol decrease | |
| Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | Rosuvastatin | -25.2 | Standard Deviation 14.0 | percentage of total cholesterol decrease | |
| Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | Atorvastatin | 4.4 | Standard Deviation 14.3 | percentage of HDL-C increase | |
| Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | Pravastatin | 7.9 | Standard Deviation 19.2 | percentage of HDL-C increase | |
| Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | Rosuvastatin | 11.3 | Standard Deviation 20.6 | percentage of HDL-C increase | |
| Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks | Atorvastatin | -19.2 | Standard Deviation 25 | percentage of triglycerides decrease |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Phase | STARTED | Initial Phase | 668 | |
| Initial Phase | STARTED | Atorvastatin | 0 | |
| Initial Phase | STARTED | Pravastatin | 0 | |
| Initial Phase | STARTED | Rosuvastatin | 0 | |
| Initial Phase | COMPLETED | Initial Phase | 317 | |
| Initial Phase | COMPLETED | Atorvastatin | 0 | |
| Initial Phase | COMPLETED | Pravastatin | 0 | |
| Initial Phase | COMPLETED | Rosuvastatin | 0 | |
| Initial Phase | NOT COMPLETED | Initial Phase | 351 | |
| Initial Phase | NOT COMPLETED | Atorvastatin | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events172
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 | Tachycardia | Cardiac disorders | Initial Phase | 0 | 317 | |
| other | Tachycardia | Cardiac disorders | Atorvastatin | 0 | 97 | |
| other | Tachycardia | Cardiac disorders | Pravastatin | 0 | 92 | |
| other | Tachycardia | Cardiac disorders | Rosuvastatin | 1 | 103 | |
| other | gingival hypoplasia | Gastrointestinal disorders | Initial Phase | 0 | 317 | |
| other | gingival hypoplasia | Gastrointestinal disorders | Atorvastatin | 1 | 97 | |
| other | gingival hypoplasia | Gastrointestinal disorders | Pravastatin | 0 | 92 | |
| other | gingival hypoplasia | Gastrointestinal disorders | Rosuvastatin | 0 | 103 | |
| other | skin discolouration | Skin and subcutaneous tissue disorders | Initial Phase | 0 | 317 | |
| other | skin discolouration | Skin and subcutaneous tissue disorders | Atorvastatin | 0 | 97 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Phase | ||
| Total, all-cause mortality | Atorvastatin | ||
| Total, all-cause mortality | Pravastatin | ||
| Total, all-cause mortality | Rosuvastatin | ||
| Total, other adverse events | Initial Phase | 6 | 317 |
| Total, other adverse events | Atorvastatin | 5 | 97 |
| Total, other adverse events | Pravastatin | 7 | 92 |
| Total, other adverse events | Rosuvastatin | 5 | 103 |
| Total, serious adverse events | Initial Phase | 2 | 317 |
| Total, serious adverse events | Atorvastatin | 4 | 97 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00631189
GET https://conductscience.org/api/trials/v1/NCT00631189/results?page=2