Cardiovascular DiseasesPhase 3NCT00352183
Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
A Phase 3 study testing Fenofibrate/Simvastatin and Simvastatin in people with Cardiovascular Diseases, run by Solvay Pharmaceuticals at 67 sites in 6 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
- Cardiovascular Diseases
- What is being tested?
- Fenofibrate/Simvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 67 sitesin 6 countries
- Study dates
- Jan 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
- Diabetes,
- 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
67 sites in 6 countries.
67 sites in 6 countries
Australia25 sites
Site 204
Adelaide
Site 214
Adelaide
Site 203
Bendigo
Site 207
Brisbane
Site 208
Brisbane
Site 221
Brisbane
Site 202
Burnie
Site 201
Camperdown
Site 220
Coffs Harbour
Site 218
Daw Park
Site 212
Elizabeth Vale
Site 217
Fitzroy
Site 222
Fremantle
Site 216
Geelong
Site 225
Ingleburn
Site 213
Kippa-Ring
Site 209
Launceston
Site 219
Liverpool
Site 223
Malvern
Site 211
Meadowbrook
Site 224
Miranda
Site 210
Nambour
Site 205
Parkville
Site 206
Sale
Site 215
Sydney
New Zealand11 sites
Site 102
Auckland
Site 103
Auckland
Site 107
Blenheim
Site 101
Christchurch
Site 108
Dunedin
Site 104
Hamilton
Site 111
Hastings
Site 106
Nelson
Site 110
Newtown, Wellington
Site 109
Takapuna, Auckland
Site 105
Tauranga
Hungary10 sites
Site 603
Balatonfüred
Site 605
Budapest
Site 608
Budapest
Site 604
Gyöngyös
Site 602
Győr
Site 610
Hódmezővásárhely
Site 609
Kecskemét
Site 601
Miskolc
Site 607
Sopron
Site 606
Székesfehérvár
Lithuania8 sites
Site 502
Alytus
Site 503
Kaunas
Site 506
Kaunas
Site 505
Klaipėda
Site 507
Klaipėda
Site 508
Palanga
Site 504
Šiauliai
Site 501
Vilnius
Estonia7 sites
Site 301
Tallinn
Site 302
Tallinn
Site 303
Tallinn
Site 305
Tallinn
Site 306
Tallinn
Site 304
Tartu
Site 307
Tartu
Latvia6 sites
Site 403
Daugavpils
Site 406
Jēkabpils
Site 401
Ogre
Site 402
Riga
Site 405
Riga
Site 404
Tukums
About this study
Official title: A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 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
- Cardiovascular Diseases
- Being tested
- Fenofibrate/Simvastatin, Simvastatin
- Keywords
- Hyperlipidemia Combined, Combination of fenofibrate and simvastatin
- Medical subject headings
- Cardiovascular Diseases
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 40mg
SimvastatinDrug
Simvastatin 40mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fenofibrate/Simvastatin |
| 2 | Active comparator | Not described Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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 posted14 Jul 2006 (estimated)
- Study startJan 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 Cardiovascular DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 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
- NCT00352183
- Sponsor's protocol ID
- C LF0242780-01 05 02
- Other IDs
- ACTRN012605000777695
- Status last verified
- Jul 2009
- First submitted
- 13 Jul 2006
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- 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 Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone.
- ClinicalTrials.gov ID
- NCT00352183
- Acronym / sponsor ID
- C LF0242780-01 05 02
- Conditions
- Cardiovascular Diseases
- Keywords
- Hyperlipidemia Combined, Combination of fenofibrate and simvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fenofibrate/Simvastatin |
| 2 | 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 (5 listed)
- Diabetes,
- 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 and Simvastatin 40mg | Drug | 1 |
| SimvastatinSimvastatin 40mg | Drug | 2 |
Primary outcome
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 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.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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
67 sites in 6 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 Cardiovascular Diseases, run by Solvay Pharmaceuticals at 67 sites in 6 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 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 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 67 sites in Australia, New Zealand, Hungary, Lithuania, Estonia and 1 more country. 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?
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.