DyslipidemiaPhase 4NCT00385658
Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
A Phase 4 study testing Fluvastatin extended release, fenofibrate and Fixed combination simvastatin/ezetimibe in people with Dyslipidemia, run by Novartis at 2 sites in 2 countries.
Trial summary
This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Fluvastatin extended release, fenofibrate and Fixed combination simvastatin/ezetimibe
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Mar 2007
- 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
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in the study prior to any study procedures.
- Male or female subjects, age between 18-75 years inclusive.
- All women of child bearing potential must have a negative pregnancy test
- Metabolic Syndrome according to the International Diabetes Federation definition:
- Low plasma HDL-C (Men < 40 mg/dl ; Women < 50 mg/dl ).
- Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
Show all 11Show fewer
- And one or more of the following criteria:
- Triglycerides ≥ 150 mg/d.l
- Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
- Fasting plasma glucose≥ 100mg/dl.
- Previously diagnosed type 2 diabetes.
Who cannot join
- Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
- Type 1 diabetes.
- HbA1c > 9.5%.
- Unexplained serum creatine phosphokinase > 2 x Upper limit of normal.
- History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
- Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome
This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.
- Conditions
- Dyslipidemia
- Being tested
- Fluvastatin extended release, fenofibrate, Fixed combination simvastatin/ezetimibe
- Keywords
- Dyslipidemia, metabolic syndrome, fluvastatin, fenofibrate, simvastatin, ezetimibe
- Medical subject headings
- Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluvastatin extended release, fenofibrateDrug
Fixed combination simvastatin/ezetimibeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
Secondary outcomes (6)
Compared at the end of each treatment period:
patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
patients reaching target levels of non-HDL-C <130mg/
LDL-C/HDL-C
Triglycerides
LDL subfractions in a subgroup of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharma AG, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385658
- Sponsor's protocol ID
- CXUO320BDE35
- Status last verified
- Feb 2017
- First submitted
- 10 Oct 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00385658
- Acronym / sponsor ID
- CXUO320BDE35
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia, metabolic syndrome, fluvastatin, fenofibrate, simvastatin, ezetimibe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 11 Oct 2006 (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.
This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent to participate in the study prior to any study procedures.
- Male or female subjects, age between 18-75 years inclusive.
- All women of child bearing potential must have a negative pregnancy test
- Metabolic Syndrome according to the International Diabetes Federation definition:
Key exclusion criteria (7 listed)
- Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
- Type 1 diabetes.
- HbA1c > 9.5%.
- Unexplained serum creatine phosphokinase > 2 x Upper limit of normal.
- History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
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 extended release, fenofibrate | Drug | – |
| Fixed combination simvastatin/ezetimibe | Drug | – |
Primary outcome
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
6 secondary outcomes
Compared at the end of each treatment period:
patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
patients reaching target levels of non-HDL-C <130mg/
LDL-C/HDL-C
Triglycerides
LDL subfractions in a subgroup of patients
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 24 Feb 2017.
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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 Pharma AG study director
Novartis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluvastatin extended release, fenofibrate and Fixed combination simvastatin/ezetimibe in people with Dyslipidemia, run by Novartis at 2 sites in 2 countries.
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 11 inclusion and 7 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 24 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 2 sites in Germany, 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 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?
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.. It is what the study was designed to measure, not a finding.
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 24 Feb 2017.