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NCT01078675 · ClinicalTrials.gov registry record · Phase 3
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
A Phase 3 study of Familial Hypercholesterolaemia, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
- 15
- Study locations
NCT01078675: Completed Phase 3 study of Familial Hypercholesterolaemia, sponsored by AstraZeneca.
NCT01078675 is a Phase 3 study of Familial Hypercholesterolaemia that has completed, run by AstraZeneca. The registered enrollment target is 315 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078675, a Phase 3 study of Familial Hypercholesterolaemia, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients. This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis. At baseline only a small number of patients will participate in a single dose PK phase over 24 hours. In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG rosuvastatin calcium
Study Locations (15)
Other
- Research Site - Leuven
- Research Site - Amsterdam
- Research Site - Groningen
- Research Site - Hoorn
- Research Site - Leiderdorp
- Research Site - Rotterdam
- Research Site - Waalwijk
- Research Site - Oslo
Ontario
- Research Site - Hamilton
- Research Site - Toronto
Quebec
- Research Site - Chicoutimi
- Research Site - Québec
Ohio
- Research Site - Cincinnati
Belgium
- Research Site - Leuven
British Columbia
- Research Site - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01078675 record still lists
NCT01078675 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Familial Hypercholesterolaemia appearing as the primary indexed condition, and to 1 intervention - of which rosuvastatin calcium is the first listed.
NCT01078675 lists 15 locations in 6 states (Other, Ontario, Quebec).
Frequently Asked Questions
What is clinical trial NCT01078675 about?
NCT01078675 is a clinical study titled "An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia". This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients. This study wi...
What is the current status of trial NCT01078675?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2010-02. Estimated completion is 2013-02.
What conditions does trial NCT01078675 study?
This clinical trial studies the following conditions: Familial Hypercholesterolaemia.
What interventions are being tested in trial NCT01078675?
The interventions under investigation include: rosuvastatin calcium (DRUG).
Who is sponsoring clinical trial NCT01078675?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01078675 being conducted?
This trial has 15 study locations across Ohio, Belgium, British Columbia, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01078675's enrollment target sits among peer trials
315 1092nd of 2000 higher than 905 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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