HyperlipidemiaPhase 3NCT00349375
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
A Phase 3 study testing Fenofibrate/Simvastatin and Simvastatin in people with Hyperlipidemia, run by Solvay Pharmaceuticals at 110 sites in 8 countries.
Trial summary
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Fenofibrate/Simvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 110 sitesin 8 countries
- Study dates
- Nov 2005to Sep 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mixed dyslipidemia
Who cannot join
- Known hypersensitivity to fenofibrate or simvastatin
- Pregnant or lactating women
- Contra-indication to fenofibrate or simvastatin
- Unstable or severe cardiac disease
Trial locations and contacts
110 sites in 8 countries.
110 sites in 8 countries
France21 sites
Site 302
Bouliac
Site 314
Briollay
Site 318
Corsept
Site 301
Dijon
Site 317
La Montagne
Site 321
Le Mesnil En Valee
Site 316
Loudon
Site 308
Mont-de-Marsan
Site 312
Mûrs-Erigné
Site 310
Nantes
Site 304
Niort
Site 319
Orvault
Site 306
Paris
Site 305
Pouilly-en-Auxois
Site 307
Rouen
Site 311
Rouen
Site 303
Saint-Justin
Site 315
Thouars
Site 309
Vieux-Condé
Site 313
Vihiers
Site 320
Vue
Czechia19 sites
Site 008
Brno
Site 009
Brno
Site 010
Brno
Site 015
Hradisk
Site 019
Karlovy Vary
Site 014
Kladno
Site 005
Nymburk
Site 012
Olomouc
Site 013
Olomouc
Site 007
Pilsen
Site 018
Pilsen
Site 001
Prague
Site 002
Prague
Site 003
Prague
Site 004
Prague
Site 016
Příbram
Site 017
Příbram
Site 011
Slaný
Site 006
Tábor
Germany15 sites
Site 109
Deidesheim
Site 108
Frankfurt
Site 101
Freiburg im Breisgau
Site 111
Hamburg
Site 103
Hanover
Site 104
Ilvesheim
Site 110
Kassel
Site 106
Mannheim
Site 114
München
Site 113
Neu-Anspach
Site 105
Offenbach
Site 107
Offenbach
Site 115
Paderborn Kernstadt
Site 102
Rodgau
Site 112
Wermsdorf
Ukraine15 sites
Site 701
Dnipropetrovsk
Site 702
Dnipropetrovsk
Site 709
Dnipropetrovsk
Site 712
Donetsk
Site 703
Kharkiv
Site 705
Kharkiv
Site 711
Kharkiv
Site 704
Kyiv
Site 706
Kyiv
Site 707
Kyiv
Site 708
Kyiv
Site 715
Kyiv
Site 713
Luhansk
Site 714
Odesa
Site 710
Zaporizhya
Netherlands14 sites
Site 511
's-Hertogenbosch
Site 508
Breda
Site 509
De Bilt
Site 502
Eindhoven
Site 514
Eindhoven
Site 503
Groningen
Site 512
Hengelo
Site 506
Leiden
Site 507
Nijmegen
Site 501
Rotterdam
Site 513
Tiel
Site 510
Utrecht
Site 505
Velp
Site 504
Zoetermeer
Hungary13 sites
Site 406
Békéscsaba
Site 401
Budapest
Site 411
Budapest
Site 412
Budapest
Site 405
Debrecen
Site 402
Gyöngyös
Site 409
Gyula
Site 410
Kecskemét
Site 404
Miskolc
Site 413
Mosonmagyaróvár
Site 407
Orosháza
Site 408
Szeged
Site 403
Szolnok
Poland10 sites
Site 606
Chrzanów
Site 601
Gdansk
Site 603
Katowice
Site 609
Sopot
Site 602
Warsaw
Site 607
Warsaw
Site 608
Warsaw
Site 605
Wroclaw
Site 610
Wroclaw
Site 604
Zabrze
About this study
Official title: A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
- Conditions
- Hyperlipidemia
- Being tested
- Fenofibrate/Simvastatin, Simvastatin
- Keywords
- Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate/SimvastatinDrug
Combination of Fenofibrate 145mg and Simvastatin 20mg
Fenofibrate/SimvastatinDrug
Combination of Fenofibrate and Simvastatin 40 mg
SimvastatinDrug
Simvastatin 40 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fenofibrate/Simvastatin |
| 2 | Experimental | Not described Receives: Drug: Fenofibrate/Simvastatin |
| 3 | Active comparator | Not described Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to 24 weeks of treatment in Triglycerides
Measured: 12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Measured: 12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Measured: 12 weeks
Secondary outcomes (3)
Percent change from baseline to 24 weeks of treatment in Triglycerides
Measured: 24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Measured: 24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startNov 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349375
- Sponsor's protocol ID
- C LF0242780-01 05 01
- Other IDs
- 2005-003270-14, 2005
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2006
- Last updated
- 8 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone
- ClinicalTrials.gov ID
- NCT00349375
- Acronym / sponsor ID
- C LF0242780-01 05 01
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Jul 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.
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fenofibrate/Simvastatin |
| 2 | Experimental | Drug: Fenofibrate/Simvastatin |
| 3 | Active comparator | Drug: Simvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mixed dyslipidemia
Key exclusion criteria (4 listed)
- Known hypersensitivity to fenofibrate or simvastatin
- Pregnant or lactating women
- Contra-indication to fenofibrate or simvastatin
- Unstable or severe cardiac disease
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 |
|---|---|---|
| Fenofibrate/SimvastatinCombination of Fenofibrate 145mg and Simvastatin 20mg | Drug | 1 |
| Fenofibrate/SimvastatinCombination of Fenofibrate and Simvastatin 40 mg | Drug | 2 |
| SimvastatinSimvastatin 40 mg | Drug | 3 |
Primary outcome
Percent change from baseline to 24 weeks of treatment in Triglycerides
Time frame: 12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Time frame: 12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Time frame: 12 weeks
3 secondary outcomes
Percent change from baseline to 24 weeks of treatment in Triglycerides
Time frame: 24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Time frame: 24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Time frame: 24 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 8 Jul 2009.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
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Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
110 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fenofibrate/Simvastatin and Simvastatin in people with Hyperlipidemia, run by Solvay Pharmaceuticals at 110 sites in 8 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 1 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 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in France, Czechia, Germany, Ukraine, Netherlands and 3 more countries. 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.
What does the primary outcome measure?
Percent change from baseline to 24 weeks of treatment in Triglycerides (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 8 Jul 2009.