HyperlipidemiaPhase 3NCT00362934
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
A Phase 3 study testing fenofibrate / simvastatin and Atorvastatin in people with Hyperlipidemia, run by Solvay Pharmaceuticals at 68 sites in 5 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 Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 68 sitesin 5 countries
- Study dates
- Oct 2006to Aug 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 fenofibrates or simvastatin or atorvastatin
- Pregnant or lactating women
- Contra-indication to fenofibrate or simvastatin or atorvastatin
- Unstable or severe cardiac disease
Trial locations and contacts
68 sites in 5 countries.
68 sites in 5 countries
Czechia17 sites
Site 109
Chrudim
Site 117
Havířov
Site 101
Olomouc
Site 114
Olomouc
Site 116
Ostrava
Site 107
Pardubice
Site 111
Pardubice
Site 113
Pilsen
Site 100
Prague
Site 104
Prague
Site 108
Prague
Site 110
Prague
Site 115
Prague
Site 103
Teplice
Site 106
Trutnov
Site 118
Uničov
Site 102
Ústí nad Orlicí
Ukraine16 sites
Site 416
Donetsk
Site 401
Kharkiv
Site 412
Kiev
Site 402
Kyiv
Site 404
Kyiv
Site 408
Kyiv
Site 410
Kyiv
Site 414
Lutsk
Site 406
Lviv
Site 407
Odesa
Site 409
Odesa
Site 411
Odesa
Site 405
Simferopol
Site 413
Uzhhorod
Site 400
Vinnitsa
Site 415
Zaporizhzhya
Slovakia13 sites
Site 301
Banská Bystrica
Site 307
Bratislava
Site 310
Bratislava
Site 311
Bratislava
Site 312
Bratislava
Site 309
Dolný Kubín
Site 302
Košice
Site 305
Lučenec
Site 306
Nitra
Site 304
Nové Zámky
Site 308
Prešov
Site 303
Vráble
Site 300
Žilina
Bulgaria12 sites
Site 501
Haskovo
Site 505
Pleven
Site 503
Plovdiv
Site 506
Plovdiv
Site 500
Sofia
Site 502
Sofia
Site 504
Sofia
Site 507
Sofia
Site 509
Sofia
Site 511
Sofia
Site 508
Varna
Site 510
Varna
Germany10 sites
Site 203
Berlin
Site 204
Bochum
Site 205
Dresden
Site 206
Görlitz
Site 202
Hamburg
Site 208
Karlsruhe
Site 207
Leipzig
Site 201
Magdeburg
Site 209
Nuremberg
Site 200
Unterschneidheim
About this study
Official title: A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin 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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
- Conditions
- Hyperlipidemia
- Being tested
- fenofibrate / simvastatin, Atorvastatin
- Keywords
- Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus atorvastatin
- 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 and simvastatin 20 mg and 40 mg
AtorvastatinDrug
Atorvastatin 10 mg and 20mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: fenofibrate / simvastatin |
| 2 | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to 12 weeks of treatment in Triglycerides
Measured: 12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
Measured: 12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C
Measured: 12 weeks
Secondary outcomes (3)
Percent change from baseline to 12 weeks of treatment in Triglycerides
Measured: 24 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
Measured: 24 weeks
Percent change from baseline to 12 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 posted15 Aug 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 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
- 516 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
- NCT00362934
- Sponsor's protocol ID
- C LF0242780-01 05 03
- Other IDs
- 2006-000519-21
- Status last verified
- Jul 2009
- First submitted
- 11 Aug 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, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone
- ClinicalTrials.gov ID
- NCT00362934
- Acronym / sponsor ID
- C LF0242780-01 05 03
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Aug 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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fenofibrate / simvastatin |
| 2 | Active comparator | Drug: Atorvastatin |
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 fenofibrates or simvastatin or atorvastatin
- Pregnant or lactating women
- Contra-indication to fenofibrate or simvastatin or atorvastatin
- 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 and simvastatin 20 mg and 40 mg | Drug | 1 |
| AtorvastatinAtorvastatin 10 mg and 20mg | Drug | 2 |
Primary outcome
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time frame: 12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
Time frame: 12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C
Time frame: 12 weeks
3 secondary outcomes
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time frame: 24 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
Time frame: 24 weeks
Percent change from baseline to 12 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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Cardiovascular Diseases, Hypertension
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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
68 sites in 5 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 Atorvastatin in people with Hyperlipidemia, run by Solvay Pharmaceuticals at 68 sites in 5 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 68 sites in Czechia, Ukraine, Slovakia, Bulgaria, 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 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 12 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.