Metabolic SyndromePhase 4NCT00138528
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
A Phase 4 study testing Fluvastatin in people with Metabolic Syndrome, run by Novartis at 1 site in Germany.
Trial summary
Other effects of fluvastatin are investigated in German patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Fluvastatin
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Feb 2006
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male and female patients, aged between 18 and 75 years
- Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)
Who cannot join
- History of heart failure
- HIV positive
- Stroke
- Other protocol defined inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Other effects of fluvastatin are investigated in German patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Fluvastatin
- Keywords
- Metabolic Syndrome, fluvastatin
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks
Secondary outcomes (5)
Change from baseline in low density lipoprotein cholesterol after 5 weeks
Change from baseline in non high density lipoprotein cholesterol after 5 weeks
Change from baseline in total cholesterol after 5 weeks
Change from baseline in high density lipoprotein cholesterol after 5 weeks
Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startOct 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 55 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
- NCT00138528
- Sponsor's protocol ID
- CXUO320BDE30
- Status last verified
- Feb 2017
- First submitted
- 25 Aug 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Westphal S, Abletshauser C, Luley C. Fluvastatin treatment and withdrawal: effects on endothelial function. Angiology. 2008 Oct-Nov;59(5):613-8. doi: 10.1177/0003319708316005. Epub 2008 Apr 14.
PubMed 18413332
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00138528
- Acronym / sponsor ID
- CXUO320BDE30
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, fluvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 30 Aug 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.
Other effects of fluvastatin are investigated in German patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Male and female patients, aged between 18 and 75 years
- Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)
Key exclusion criteria (4 listed)
- History of heart failure
- HIV positive
- Stroke
- 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
Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks
5 secondary outcomes
Change from baseline in low density lipoprotein cholesterol after 5 weeks
Change from baseline in non high density lipoprotein cholesterol after 5 weeks
Change from baseline in total cholesterol after 5 weeks
Change from baseline in high density lipoprotein cholesterol after 5 weeks
Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks
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 23 Feb 2017.
- Results publication: PubMed 18413332Westphal S, Abletshauser C, Luley C. Fluvastatin treatment and withdrawal: effects on endothelial function. Angiology. 2008 Oct-Nov;59(5):613-8. doi: 10.1177/0003319708316005. Epub 2008 Apr 14.
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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 4 study testing Fluvastatin in people with Metabolic Syndrome, run by Novartis at 1 site in Germany.
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 3 inclusion and 4 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 23 Feb 2017. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00138528, which also lists 1 linked publication.
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 23 Feb 2017.