Trial · NCT00355615
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
NCT00355615, Phase 3, Completed, AstraZeneca; results first posted 2009-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin. Trials, record NCT00355615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00355615
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
- NCT number
- NCT00355615
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 173 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Familial Hypercholesterolemia
- Interventions
- Rosuvastatin, Placebo
- First posted
- 2006-07-24
- Last updated
- 2011-08-31
- Results first posted
- 2009-07-20
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 in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | 12 weeks | Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100 |
| Secondary | Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | 6 weeks | Percent change from baseline in LDL-C after six week of treatment |
| Secondary | Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment | 12 weeks | Percent of patients achieving LDL-C \< 110 mg/dL out of the total patients in each treatment group |
| Secondary | Percent Change in HDL-C | After 12 weeks of treatment | Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment |
| Secondary | Percent Change in Non-HDL-C at 12 Weeks | After 12 weeks of treatment | Percent change in non-HDL-C at 12 weeks |
| Secondary | Percent Change in Triglycerides (TG) | After 12 weeks of treatment | Percent change in tryglycerides (TG) after 12 weeks of treatment |
| Secondary | Percent Change in Total Cholesterol (TC) | After 12 weeks of treatment | Percent change from baseline in total cholesteral after 12 weeks of treatment |
| Secondary | Percent Change in Apolipoprotein A-1 (ApoA-1) | After 12 weeks of treatment | Percent change in ApoA-1 after 12 weeks of treatment |
| Secondary | Percent Change in Apolipoprotein B (ApoB) | After 12 weeks of treatment | Percent change in ApoB after 12 weeks of treatment |
| Secondary | Percent Change in ApoB/ApoA-1 | After 12 weeks of treatment | Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment |
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 in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | 12 weeks | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | percentage | MEAN |
| SECONDARY | Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | 6 weeks | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | percentage | MEAN |
| SECONDARY | Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment | 12 weeks | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Percent of Participants | NUMBER |
| SECONDARY | Percent Change in HDL-C | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | percent change | MEAN |
| SECONDARY | Percent Change in Non-HDL-C at 12 Weeks | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | percent change | MEAN |
| SECONDARY | Percent Change in Triglycerides (TG) | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | percent change | MEAN |
| SECONDARY | Percent Change in Total Cholesterol (TC) | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | percent change | MEAN |
| SECONDARY | Percent Change in Apolipoprotein A-1 (ApoA-1) | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | mean percent change | MEAN |
| SECONDARY | Percent Change in Apolipoprotein B (ApoB) | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | mean percent change | MEAN |
| SECONDARY | Percent Change in ApoB/ApoA-1 | After 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | mean percent change | 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 in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | Rosuva 5 | -38.5 | Standard Deviation 11.38 | percentage | |
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | Rosuva 10 | -44.4 | Standard Deviation 12.15 | percentage | |
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | Rosuva 20 | -50.2 | Standard Deviation 13.3 | percentage | |
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | Placebo | -0.5 | Standard Deviation 13.18 | percentage | |
| Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | Rosuva 5 | -40.3 | Standard Deviation 12.22 | percentage | |
| Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | Rosuva 10 | -45.2 | Standard Deviation 11.15 | percentage | |
| Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | Rosuva 20 | -50.0 | Standard Deviation 11.42 | percentage | |
| Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | Placebo | -0.6 | Standard Deviation 13.63 | percentage | |
| Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment | Rosuva 5 | 11.9 | Percent of Participants | ||
| Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment | Rosuva 10 | 40.9 | Percent of Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Double Blind Period | STARTED | Rosuva 5 | 42 | |
| Randomized Double Blind Period | STARTED | Rosuva 10 | 44 | |
| Randomized Double Blind Period | STARTED | Rosuva 20 | 45 | |
| Randomized Double Blind Period | STARTED | Placebo | 46 | |
| Randomized Double Blind Period | STARTED | Rosuva ol | 0 | |
| Randomized Double Blind Period | COMPLETED | Rosuva 5 | 41 | |
| Randomized Double Blind Period | COMPLETED | Rosuva 10 | 44 | |
| Randomized Double Blind Period | COMPLETED | Rosuva 20 | 44 | |
| Randomized Double Blind Period | COMPLETED | Placebo | 45 | |
| Randomized Double Blind Period | COMPLETED | Rosuva ol | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events45
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 | Fatigue | General disorders | Rosuva 5 | 1 | 42 | |
| other | Fatigue | General disorders | Rosuva 10 | 1 | 44 | |
| other | Fatigue | General disorders | Rosuva 20 | 1 | 44 | |
| other | Fatigue | General disorders | Placebo | 0 | 46 | |
| other | Fatigue | General disorders | Rosuva ol | 9 | 173 | |
| other | Headache | Nervous system disorders | Rosuva 5 | 6 | 42 | |
| other | Headache | Nervous system disorders | Rosuva 10 | 7 | 44 | |
| other | Headache | Nervous system disorders | Rosuva 20 | 9 | 44 | |
| other | Headache | Nervous system disorders | Placebo | 9 | 46 | |
| other | Headache | Nervous system disorders | Rosuva ol | 29 | 173 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuva 5 | ||
| Total, all-cause mortality | Rosuva 10 | ||
| Total, all-cause mortality | Rosuva 20 | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rosuva ol | ||
| Total, other adverse events | Rosuva 5 | 12 | |
| Total, other adverse events | Rosuva 10 | 14 | |
| Total, other adverse events | Rosuva 20 | 17 | |
| Total, other adverse events | Placebo | 17 | |
| Total, other adverse events | Rosuva ol | 75 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20223367 | 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/NCT00355615
GET https://conductscience.org/api/trials/v1/NCT00355615/results?page=2