Metabolic SyndromePhase 4NCT00664742

The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome

A Phase 4 study testing Fluvastatin XL® in people with Metabolic Syndrome, run by Novartis at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome Read more about this study

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Fluvastatin XL®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 614 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Sep 2006to Oct 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
Written informed consent for participating in the study

Who cannot join

Severe renal disease or renal dysfunction
Chronic liver disease or liver function impairment
Inflammatory muscle dysfunction or findings of muscle problems
Severe cardiac failure
Other protocol defined inclusion exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Götzepe Education and Research Hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome

This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

Conditions: Metabolic Syndrome
Being tested: Fluvastatin XL®
Keywords: Metabolic syndrome,dyslipidemia,fluvastatin extended release
Medical subject headings: Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluvastatin XL®Drug
Also called Lescol XL
Fluvastatin extended release 80 mg

Study groups in NCT00664742
Study group	Role	What they receive
Fluvastatin XL® Treatment	Experimental	80 mg once daily, at bedtime. Receives: Drug: Fluvastatin XL®

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6
Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.
Measured: Baseline,6 weeks

Secondary outcomes (1)

Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels
The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.
Measured: Baseline, 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Oct 2007

First posted23 Apr 2008 (estimated)
Study startSep 2006
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 614 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00664742
Sponsor's protocol ID: CXUO320BTR03
Status last verified: Apr 2011
First submitted: 21 Apr 2008
Last updated: 17 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
ClinicalTrials.gov ID: NCT00664742
Acronym / sponsor ID: CXUO320BTR03
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome,dyslipidemia,fluvastatin extended release
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 614 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 23 Apr 2008 (estimated)
Results: Posted 17 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fluvastatin XL® Treatment	Experimental	Drug: Fluvastatin XL®80 mg once daily, at bedtime.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
Written informed consent for participating in the study

Key exclusion criteria (5 listed)

Severe renal disease or renal dysfunction
Chronic liver disease or liver function impairment
Inflammatory muscle dysfunction or findings of muscle problems
Severe cardiac failure
Other protocol defined inclusion 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 XL®Also: Lescol XLFluvastatin extended release 80 mg	Drug	Fluvastatin XL® Treatment

Primary outcome

Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6
Time frame: Baseline,6 weeks
Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.

1 secondary outcome

Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels
Time frame: Baseline, 6 weeks

Results and safety

Results posted to the registry on 17 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluvastatin XL® Treatment	607	481

Primary outcome: Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6

Time frame: Baseline,6 weeks. Mean (95% Confidence Interval). Unit: mg/dL

Measure	Fluvastatin XL® Treatment n = 481
Change in TC	-50.4 (28.99897)
Change in HDL-C	-0.6 (12.30119)
Change in LDL-C	-45.2 (62.92132)
Change in TG	-22.3 (71.50801)

Population analysed: The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluvastatin XL® Treatment	2 of 607 (0.3%)	0 of 607 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
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Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

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.

The record lists no contact. Use the official record to reach the sponsor.

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 XL® in people with Metabolic Syndrome, run by Novartis at 1 site in Turkey (Türkiye).

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 5 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 17 May 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 Turkey (Türkiye). 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?

Yes. Results are posted in the registry (first posted 17 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6 (time frame: Baseline,6 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 NCT00664742.

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 17 May 2011.