DyslipidemiaPhase 3NCT00300482
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
A Phase 3 study testing ABT-335 and Rosuvastatin Calcium in people with Dyslipidemia and Coronary Heart Disease, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- What is being tested?
- ABT-335 and Rosuvastatin Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,445 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mixed dyslipidemia
Who cannot join
- Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
- Patients who are taking certain medications or unstable dose of specific medications.
- Women who are pregnant or plan on becoming pregnant or women who are lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information
North Chicago, Illinois, 60064
About this study
Official title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.
- Conditions
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Being tested
- ABT-335, Rosuvastatin Calcium, Placebo
- Keywords
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Medical subject headings
- Dyslipidemias, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-335Drug
135 mg, daily, 12 weeks
Rosuvastatin CalciumDrug
Also called Rosuvastatin
Daily, 12 weeks, see Arm Description for dosage information
PlaceboDrug
Daily, 12 weeks, see Arm Description for information regarding placebo type
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | ABT-335 + 10 mg rosuvastatin Receives: Drug: ABT-335; Drug: Rosuvastatin Calcium |
| B | Active comparator | ABT-335 + 20 mg rosuvastatin Receives: Drug: ABT-335; Drug: Rosuvastatin Calcium |
| C | Placebo comparator | ABT-335 monotherapy Receives: Drug: ABT-335; Drug: Placebo |
| D | Placebo comparator | 10 mg rosuvastatin monotherapy Receives: Drug: Rosuvastatin Calcium; Drug: Placebo |
| E | Placebo comparator | 20 mg rosuvastatin monotherapy Receives: Drug: Rosuvastatin Calcium; Drug: Placebo |
| F | Placebo comparator | 40 mg rosuvastatin monotherapy Receives: Drug: Rosuvastatin Calcium; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Triglycerides From Baseline to Final Visit
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Measured: Baseline to 12 Weeks
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Measured: Baseline to 12 Weeks
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100
Measured: Baseline to 12 Weeks
Secondary outcomes (5)
Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
Measured: Baseline to 12 Weeks
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
Measured: Baseline to 12 Weeks
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100
Measured: Baseline to 12 Weeks
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100
Measured: Baseline to 12 Weeks
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100
Measured: Baseline to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2006
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.
- Publications (6)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maureen Kelly, MD, Principal investigator, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300482
- Sponsor's protocol ID
- M05-748
- Status last verified
- Jun 2009
- First submitted
- 7 Mar 2006
- Last updated
- 10 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25. doi: 10.2165/11597940-000000000-00000.
PubMed 22263674Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57. doi: 10.1007/s10557-010-6273-5.
PubMed 21174145Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. doi: 10.2337/dc10-0357. Epub 2010 Jun 23.
PubMed 20573750Jones PH, Cusi K, Davidson MH, Kelly MT, Setze CM, Thakker K, Sleep DJ, Stolzenbach JC. Efficacy and safety of fenofibric acid co-administered with low- or moderate-dose statin in patients with mixed dyslipidemia and type 2 diabetes mellitus: results of a pooled subgroup analysis from three randomized, controlled, double-blind trials. Am J Cardiovasc Drugs. 2010;10(2):73-84. doi: 10.2165/10061630-000000000-00000.
PubMed 20136164Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5.
PubMed 18996523Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34. doi: 10.2165/00044011-200828100-00003.
PubMed 18783301
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT00300482
- Acronym / sponsor ID
- M05-748
- Conditions
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Keywords
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,445 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 9 Mar 2006 (estimated)
- Results
- Posted 25 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ABT-335, Drug: Rosuvastatin CalciumABT-335 + 10 mg rosuvastatin |
| B | Active comparator | Drug: ABT-335, Drug: Rosuvastatin CalciumABT-335 + 20 mg rosuvastatin |
| C | Placebo comparator | Drug: ABT-335, Drug: PlaceboABT-335 monotherapy |
| D | Placebo comparator | Drug: Rosuvastatin Calcium, Drug: Placebo10 mg rosuvastatin monotherapy |
| E | Placebo comparator | Drug: Rosuvastatin Calcium, Drug: Placebo20 mg rosuvastatin monotherapy |
| F | Placebo comparator | Drug: Rosuvastatin Calcium, Drug: Placebo40 mg rosuvastatin monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mixed dyslipidemia
Key exclusion criteria (3 listed)
- Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
- Patients who are taking certain medications or unstable dose of specific medications.
- Women who are pregnant or plan on becoming pregnant or women who are lactating.
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 |
|---|---|---|
| ABT-335135 mg, daily, 12 weeks | Drug | A, B, C |
| Rosuvastatin CalciumAlso: RosuvastatinDaily, 12 weeks, see Arm Description for dosage information | Drug | A, B, D, E, F |
| PlaceboDaily, 12 weeks, see Arm Description for information regarding placebo type | Drug | C, D, E, F |
Primary outcome
Mean Percent Change in Triglycerides From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100
5 secondary outcomes
Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22263674Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25. doi: 10.2165/11597940-000000000-00000.
- Derived from this study: PubMed 21174145Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57. doi: 10.1007/s10557-010-6273-5.
- Derived from this study: PubMed 20573750Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. doi: 10.2337/dc10-0357. Epub 2010 Jun 23.
- Derived from this study: PubMed 20136164Jones PH, Cusi K, Davidson MH, Kelly MT, Setze CM, Thakker K, Sleep DJ, Stolzenbach JC. Efficacy and safety of fenofibric acid co-administered with low- or moderate-dose statin in patients with mixed dyslipidemia and type 2 diabetes mellitus: results of a pooled subgroup analysis from three randomized, controlled, double-blind trials. Am J Cardiovasc Drugs. 2010;10(2):73-84. doi: 10.2165/10061630-000000000-00000.
- Derived from this study: PubMed 18996523Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5.
- Derived from this study: PubMed 18783301Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34. doi: 10.2165/00044011-200828100-00003.
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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.
Maureen Kelly, MD principal investigator
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABT-335 and Rosuvastatin Calcium in people with Dyslipidemia and Coronary Heart Disease, run by Abbott at 1 site in United States.
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 3 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 10 Jun 2009. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2009). 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?
Mean Percent Change in Triglycerides From Baseline to Final Visit (time frame: Baseline to 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?
On the ClinicalTrials.gov record for NCT00300482, which also lists 6 linked publications.
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 10 Jun 2009.