Trial · NCT01078675
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
NCT01078675, Phase 3, Completed, AstraZeneca; results first posted 2015-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia. Trials, record NCT01078675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01078675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
- NCT number
- NCT01078675
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 315 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Familial Hypercholesterolaemia
- Interventions
- rosuvastatin calcium, rosuvastatin calcium, rosuvastatin calcium
- First posted
- 2010-03-02
- Last updated
- 2015-04-07
- Results first posted
- 2015-02-02
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 LDL-C | At Month 3, Month 12 and Month 24 | Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Primary | Sexual Maturation by Tanner Staging at Baseline | At Baseline | Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Primary | Single Dose PK - Cmax | Serial blood samples over 24 hours. | Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing |
| Primary | Percent Change From Baseline in Height | At Month 12 and Month 24 | One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Primary | Sexual Maturation by Tanner Staging at Month 12 | At Baseline | Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Primary | Sexual Maturation by Tanner Staging at Month 24 | At Baseline | Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Primary | Single Dose PK - Tmax | Serial blood samples over 24 hours | Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing |
| Primary | Single Dose PK - AUC(0-24) | Serial blood samples over 24 hours | Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing |
| Secondary | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | At Month 3, Month 12 and Month 24 | One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Secondary | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | At Month 12 and Month 24 | One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
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 LDL-C | At Month 3, Month 12 and Month 24 | Intent-to-treat analysis set and Per-protocol analysis set | Percentage change | MEAN |
| PRIMARY | Sexual Maturation by Tanner Staging at Baseline | At Baseline | Safety analysis set | Participants | NUMBER |
| PRIMARY | Single Dose PK - Cmax | Serial blood samples over 24 hours. | Single dose PK analysis set | ng/mL | MEAN |
| SECONDARY | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | At Month 3, Month 12 and Month 24 | Intent-to-treat analysis set (LOCF) | Percent change | MEAN |
| SECONDARY | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | At Month 12 and Month 24 | Intent-to-treat analysis set (LOCF) and healthy siblings | mm | MEAN |
| SECONDARY | Adverse Events | 2-year study period | Safety analysis set | Participant | NUMBER |
| SECONDARY | Total Duration of Exposure | 2-year study period | Safety analysis set | Days | MEAN |
| PRIMARY | Percent Change From Baseline in Height | At Month 12 and Month 24 | Safety Population | Percent change | MEAN |
| PRIMARY | Sexual Maturation by Tanner Staging at Month 12 | At Baseline | Safety analysis set | Participants | NUMBER |
| PRIMARY | Sexual Maturation by Tanner Staging at Month 24 | At Baseline | Safety analysis set | Participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group80
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 LDL-C | Rosuvastatin | LDL-C %Change from Baseline at month 3 | -37.86 | Standard Deviation 14.392 | Percentage change |
| Percent Change From Baseline in LDL-C | Rosuvastatin | LDL-C %Change from Baseline at month 12 | -43.67 | Standard Deviation 14.896 | Percentage change |
| Percent Change From Baseline in LDL-C | Rosuvastatin | LDL-C %Change from Baseline at month 24 | -42.88 | Standard Deviation 18.222 | Percentage change |
| Sexual Maturation by Tanner Staging at Baseline | Rosuvastatin | Tanner Stage I at Baseline | 81 | NA | Participants |
| Sexual Maturation by Tanner Staging at Baseline | Rosuvastatin | Tanner Stage II at Baseline | 32 | NA | Participants |
| Sexual Maturation by Tanner Staging at Baseline | Rosuvastatin | Tanner Stage III at Baseline | 18 | NA | Participants |
| Sexual Maturation by Tanner Staging at Baseline | Rosuvastatin | Tanner Stage IV at Baseline | 44 | NA | Participants |
| Sexual Maturation by Tanner Staging at Baseline | Rosuvastatin | Tanner Stage V at Baseline | 21 | NA | Participants |
| Sexual Maturation by Tanner Staging at Baseline | Rosuvastatin | Not Recorded at Baseline | 1 | Participants | |
| Single Dose PK - Cmax | Rosuvastatin | 3.5717 | Standard Deviation 3.22350 | ng/mL |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosuvastatin | 250 | |
| Overall Study | STARTED | Healthy Siblings | 65 | |
| Overall Study | Patients Treated | Rosuvastatin | 198 | |
| Overall Study | Patients Treated | Healthy Siblings | 0 | |
| Overall Study | COMPLETED | Rosuvastatin | 182 | |
| Overall Study | COMPLETED | Healthy Siblings | 59 | |
| Overall Study | NOT COMPLETED | Rosuvastatin | 68 | |
| Overall Study | NOT COMPLETED | Healthy Siblings | 6 |
Source ClinicalTrials.gov
Adverse events197
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 | Lymphadenopathy | Blood and lymphatic system disorders | Rosuvastatin | 2 | 197 | 2 |
| other | Pectus carinatum | Congenital, familial and genetic disorders | Rosuvastatin | 1 | 197 | 2 |
| other | Auricular swelling | Ear and labyrinth disorders | Rosuvastatin | 1 | 197 | 1 |
| other | Deafness unilateral | Ear and labyrinth disorders | Rosuvastatin | 1 | 197 | 1 |
| other | Ear discomfort | Ear and labyrinth disorders | Rosuvastatin | 1 | 197 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Rosuvastatin | 2 | 197 | 2 |
| other | Middle ear effusion | Ear and labyrinth disorders | Rosuvastatin | 1 | 197 | 1 |
| other | Motion sickness | Ear and labyrinth disorders | Rosuvastatin | 2 | 197 | 2 |
| other | Early menarche | Endocrine disorders | Rosuvastatin | 1 | 197 | 1 |
| other | Hypothyroidism | Endocrine disorders | Rosuvastatin | 1 | 197 | 1 |
1 to 10 of 197Source ClinicalTrials.gov
See all 197 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin | ||
| Total, other adverse events | Rosuvastatin | 172 | 197 |
| Total, serious adverse events | Rosuvastatin | 9 | 197 |
Source ClinicalTrials.gov
Papers3
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/NCT01078675
GET https://conductscience.org/api/trials/v1/NCT01078675/results?page=2