DyslipidemiaPhase 3NCT00300430

Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

A Phase 3 study testing ABT-335 and rosuvastatin calcium, ABT-335 and atorvastatin calcium and ABT-335 and simvastatin in people with Dyslipidemia and Coronary Heart Disease, run by Abbott at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with 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, ABT-335 and atorvastatin calcium and ABT-335 and simvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,911 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Mar 2008
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

Adult male and female subjects who voluntarily sign the informed consent.
Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Who cannot join

Subject is using or will use investigational medications, except as approved by Abbott.
Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

Trial locations and contacts

1 site in 1 country.

United States1 site

Global Medical Information
North Chicago, Illinois, 60064

Other trials in United States

About this study

Official title: A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

Conditions: Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Being tested: ABT-335 and rosuvastatin calcium, ABT-335 and atorvastatin calcium, ABT-335 and simvastatin
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-335 and rosuvastatin calciumDrug
Also called ABT-335, TRILIPIX
ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
ABT-335 and atorvastatin calciumDrug
Also called ABT-335, TRILIPIX
ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
ABT-335 and simvastatinDrug
Also called ABT-335, TRILIPIX
ABT-335 135 mg plus simvastatin daily, 52 weeks

Study groups in NCT00300430
Study group	Role	What they receive
A	Active comparator	20 mg drug and ABT-335 Receives: Drug: ABT-335 and rosuvastatin calcium
B	Active comparator	40 mg drug and ABT 335 Receives: Drug: ABT-335 and atorvastatin calcium
C	Active comparator	40 mg drug and ABT-335 Receives: Drug: ABT-335 and simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
Measured: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy

Secondary outcomes (8)

Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
Measured: Baseline to Week 52 in this open-label study
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
Measured: Baseline to Week 52 of the open-label study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Mar 2008

First posted9 Mar 2006 (estimated)
Study startSep 2006
Primary completionMar 2008

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 (2)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: None (open label)
Enrolment: 1,911 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00300430
Sponsor's protocol ID: M05-758
Status last verified: Jun 2009
First submitted: 7 Mar 2006
Last updated: 23 Jul 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 22263674
Jones 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia
ClinicalTrials.gov ID: NCT00300430
Acronym / sponsor ID: M05-758
Conditions: Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,911 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Mar 2008 (actual)
First posted: 9 Mar 2006 (estimated)
Results: Posted 23 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Active comparator	Drug: ABT-335 and rosuvastatin calcium20 mg drug and ABT-335
B	Active comparator	Drug: ABT-335 and atorvastatin calcium40 mg drug and ABT 335
C	Active comparator	Drug: ABT-335 and simvastatin40 mg drug and ABT-335

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult male and female subjects who voluntarily sign the informed consent.
Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Key exclusion criteria (2 listed)

Subject is using or will use investigational medications, except as approved by Abbott.
Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

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-335 and rosuvastatin calciumAlso: ABT-335, TRILIPIXABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks	Drug	A
ABT-335 and atorvastatin calciumAlso: ABT-335, TRILIPIXABT-335 135 mg plus atorvastatin calcium daily, 52 weeks	Drug	B
ABT-335 and simvastatinAlso: ABT-335, TRILIPIXABT-335 135 mg plus simvastatin daily, 52 weeks	Drug	C

Primary outcome

Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
Time frame: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy

8 secondary outcomes

Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
Time frame: Baseline to Week 52 in this open-label study
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study

Results and safety

Results posted to the registry on 23 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABT-335 + 20 mg Rosuvastatin	1,186	819
ABT-335 + 40 mg Simvastatin	514	345
ABT-335 + 40 mg Atorvastatin	501	350

Primary outcome: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study

Time frame: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy. Number. Unit: percentage of participants

Measure	ABT-335 + 20 mg Rosuvastatin n = 1186	ABT-335 + 40 mg Simvastatin n = 514	ABT-335 + 40 mg Atorvastatin n = 501
Value	83	86	85

Population analysed: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT-335 + 20 mg Rosuvastatin	85 of ?	646 of ?	Not reported
ABT-335 + 40 mg Simvastatin	40 of ?	308 of ?	Not reported
ABT-335 + 40 mg Atorvastatin	23 of ?	283 of ?	Not reported

Limitations and caveats (from the sponsor): This was an open-label study designed to assess the longer-term safety of the combination therapies. Evaluation of efficacy outcomes was a secondary objective.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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 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.

Related trials for Dyslipidemia

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Lipid Metabolism Disorders
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 2 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 23 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 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. 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 23 Jul 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?

Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study (time frame: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy). 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 NCT00300430, which also lists 2 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 23 Jul 2009.