Heterozygous Familial HypercholesterolemiaPhase 3NCT00171236
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
A Phase 3 study testing Fluvastatin in people with Heterozygous Familial Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis at 1 site in Switzerland.
Trial summary
The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Heterozygous Familial Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- Fluvastatin
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2001to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10-16 years old Heterozygous familial hypercholesterolemia
Who cannot join
- Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia
- Being tested
- Fluvastatin
- Keywords
- Heterozygous familial hypercholesterolemia, mixed dyslipidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171236
- Sponsor's protocol ID
- CXUO320B2301
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 8 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00171236
- Acronym / sponsor ID
- CXUO320B2301
- Keywords
- Heterozygous familial hypercholesterolemia, mixed dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 10-16 years old Heterozygous familial hypercholesterolemia
Key exclusion criteria (2 listed)
- Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study
- Other protocol defined inclusion and exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluvastatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluvastatin in people with Heterozygous Familial Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.