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COMPLETED Phase 3

An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia

NCT01078675 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 315 participants
Start Date 2010-02
Est. Completion 2013-02
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01078675

The ClinicalTrials.gov registry entry for NCT01078675 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01078675 reports 15 study locations spanning 6 distinct geographic areas — top geographies include Other, Ontario, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01078675?

The interventions under investigation include: rosuvastatin calcium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01078675?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial