Trial · NCT02226198
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
NCT02226198, Phase 3, Completed, AstraZeneca; results first posted 2016-07-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia. Trials, record NCT02226198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02226198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
- NCT number
- NCT02226198
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Homozygous Familial Hypercholesterolemia (HoFH)
- Interventions
- Rosuvastatin 20mg, Placebo
- First posted
- 2014-08-27
- Last updated
- 2016-07-04
- Results first posted
- 2016-07-04
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LDL-Cholesterol (mg/dL) | Samples taken on Day 42 (week 6) and on day 84 (week 12) | Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment |
| Primary | LDL-Cholesterol (mmol/L) | Samples taken on Day 42 (week 6) and on day 84 (week 12) | Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment |
| Secondary | TC (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of total cholesterol (TC) |
| Secondary | TC (mmol/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of total cholesterol (TC) |
| Secondary | Non-HDL C (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) |
| Secondary | Non-HDL C (mmol/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) |
| Secondary | ApoB (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of apolipoprotein B (ApoB) |
| Secondary | ApoB (g/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of apolipoprotein B (ApoB) |
| Secondary | HDL-C (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of high density lipoprotein cholesterol (HDL C) |
| Secondary | HDL-C (mmol/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | Efficacy in terms of high density lipoprotein cholesterol (HDL C) |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LDL-Cholesterol (mg/dL) | Samples taken on Day 42 (week 6) and on day 84 (week 12) | 6-17 years HoFH | mg/dL | MEAN |
| PRIMARY | LDL-Cholesterol (mmol/L) | Samples taken on Day 42 (week 6) and on day 84 (week 12) | 6-17 years HoFH | mmol/L | MEAN |
| SECONDARY | TC (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mg/dL | MEAN | |
| SECONDARY | TC (mmol/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mmol/L | MEAN | |
| SECONDARY | Non-HDL C (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mg/dL | MEAN | |
| SECONDARY | Non-HDL C (mmol/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mmol/L | MEAN | |
| SECONDARY | ApoB (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mg/dL | MEAN | |
| SECONDARY | ApoB (g/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | g/L | MEAN | |
| SECONDARY | HDL-C (mg/dL) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mg/dL | MEAN | |
| SECONDARY | HDL-C (mmol/L) | Samples taken at Day 42 (week 6) and Day 84 (week 12) | mmol/L | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group625
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LDL-Cholesterol (mg/dL) | C-FAS Rosuvastatin | 396.0 | Standard Deviation 195.99 | mg/dL | |
| LDL-Cholesterol (mg/dL) | C-FAS Placebo | 481.4 | Standard Deviation 184.90 | mg/dL | |
| LDL-Cholesterol (mmol/L) | C-FAS Rosuvastatin | 10.26 | Standard Deviation 5.076 | mmol/L | |
| LDL-Cholesterol (mmol/L) | C-FAS Placebo | 12.47 | Standard Deviation 4.790 | mmol/L | |
| TC (mg/dL) | C-FAS Rosuvastatin | 447.6 | Standard Deviation 195.46 | mg/dL | |
| TC (mg/dL) | C-FAS Placebo | 539.0 | Standard Deviation 184.91 | mg/dL | |
| TC (mmol/L) | C-FAS Rosuvastatin | 11.59 | Standard Deviation 5.063 | mmol/L | |
| TC (mmol/L) | C-FAS Placebo | 13.96 | Standard Deviation 4.790 | mmol/L | |
| Non-HDL C (mg/dL) | C-FAS Rosuvastatin | 412.1 | Standard Deviation 198.62 | mg/dL | |
| Non-HDL C (mg/dL) | C-FAS Placebo | 505.3 | Standard Deviation 186.39 | mg/dL |
1 to 10 of 625Source ClinicalTrials.gov
See all 625 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-in Phase | STARTED | Overall | 11 | |
| Lead-in Phase | STARTED | Rosuva First Then Placebo | 0 | |
| Lead-in Phase | STARTED | Placebo First Then Rosuva | 0 | |
| Lead-in Phase | COMPLETED | Overall | 10 | |
| Lead-in Phase | COMPLETED | Rosuva First Then Placebo | 0 | |
| Lead-in Phase | COMPLETED | Placebo First Then Rosuva | 0 | |
| Lead-in Phase | NOT COMPLETED | Overall | 1 | |
| Lead-in Phase | NOT COMPLETED | Rosuva First Then Placebo | 0 | |
| Lead-in Phase | NOT COMPLETED | Placebo First Then Rosuva | 0 | |
| Cross-Over: First Intervention (6 Weeks) | STARTED | Overall | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events21
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 | Influenza like illness | General disorders | Lead-in | 2 | 11 | 2 |
| other | Influenza like illness | General disorders | Cross-over | 2 | 14 | 2 |
| other | Influenza like illness | General disorders | Maintenance | 0 | 13 | 0 |
| other | Peripheral swelling | General disorders | Lead-in | 1 | 11 | 1 |
| other | Peripheral swelling | General disorders | Cross-over | 0 | 14 | 0 |
| other | Peripheral swelling | General disorders | Maintenance | 0 | 13 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lead-in | 1 | 11 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cross-over | 0 | 14 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Maintenance | 0 | 13 | 0 |
| other | Influenza | Infections and infestations | Lead-in | 0 | 11 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lead-in | ||
| Total, all-cause mortality | Cross-over | ||
| Total, all-cause mortality | Maintenance | ||
| Total, other adverse events | Lead-in | 4 | 11 |
| Total, other adverse events | Cross-over | 4 | 14 |
| Total, other adverse events | Maintenance | 1 | 13 |
| Total, serious adverse events | Lead-in | 0 | 11 |
| Total, serious adverse events | Cross-over | 0 | 14 |
| Total, serious adverse events | Maintenance | 0 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28838366 | 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/NCT02226198
GET https://conductscience.org/api/trials/v1/NCT02226198/registered?page=2