DyslipidemiaPhase 3NCT00300456

Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

A Phase 3 study testing 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 purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin 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 Simvastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 657 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Mar 2007
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

Subjects with mixed dyslipidemia
Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

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

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia

Conditions: Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Being tested: ABT-335, Simvastatin, 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
SimvastatinDrug
daily, 12 weeks, see Arm Description for dosage information
PlaceboDrug
Daily, 12 weeks, see Arm Description for placebo information

Study groups in NCT00300456
Study group	Role	What they receive
A	Active comparator	ABT-335 + 20 mg simvastatin Receives: Drug: ABT-335; Drug: Simvastatin
B	Active comparator	ABT-335 + 40 mg simvastatin Receives: Drug: ABT-335; Drug: Simvastatin
C	Placebo comparator	ABT-335 monotherapy Receives: Drug: ABT-335; Drug: Placebo
D	Placebo comparator	20 mg simvastatin monotherapy Receives: Drug: Simvastatin; Drug: Placebo
E	Placebo comparator	40 mg simvastatin monotherapy Receives: Drug: Simvastatin; Drug: Placebo
F	Placebo comparator	80 mg simvastatin monotherapy Receives: Drug: Simvastatin; 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 (Final Visit)
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 (Final Visit)
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 (Final Visit)

Secondary outcomes (5)

Mean Percent Change in Non-high-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 (Final Visit)
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 (Final Visit)
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 (Final Visit)
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 (Final Visit)
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 (Final Visit)

Timeline

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

Mar 2006Mar 2007

First posted9 Mar 2006 (estimated)
Study startMar 2006
Primary completionMar 2007

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 (3)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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 657 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00300456
Sponsor's protocol ID: M05-749
Status last verified: May 2009
First submitted: 7 Mar 2006
Last updated: 3 Jun 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bays 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 20573750
Jones 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 20136164
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 3 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 ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia
ClinicalTrials.gov ID: NCT00300456
Acronym / sponsor ID: M05-749
Conditions: Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Keywords: Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 657 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Mar 2007 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
A	Active comparator	Drug: ABT-335, Drug: SimvastatinABT-335 + 20 mg simvastatin
B	Active comparator	Drug: ABT-335, Drug: SimvastatinABT-335 + 40 mg simvastatin
C	Placebo comparator	Drug: ABT-335, Drug: PlaceboABT-335 monotherapy
D	Placebo comparator	Drug: Simvastatin, Drug: Placebo20 mg simvastatin monotherapy
E	Placebo comparator	Drug: Simvastatin, Drug: Placebo40 mg simvastatin monotherapy
F	Placebo comparator	Drug: Simvastatin, Drug: Placebo80 mg simvastatin monotherapy

Who may qualify

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

Key inclusion criteria (2 listed)

Subjects with mixed dyslipidemia
Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

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
Simvastatindaily, 12 weeks, see Arm Description for dosage information	Drug	A, B, D, E, F
PlaceboDaily, 12 weeks, see Arm Description for placebo information	Drug	C, D, E, F

Primary outcome

Mean Percent Change in Triglycerides From Baseline to Final Visit
Time frame: Baseline to 12 Weeks (Final Visit)
[(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 (Final Visit)
[(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 (Final Visit)
[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100

5 secondary outcomes

Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit
Time frame: Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
Time frame: Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks (Final Visit)
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
Time frame: Baseline to 12 Weeks (Final Visit)

Results and safety

Results posted to the registry on 25 Mar 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 Simvastatin	119	103
ABT-335 + 40 mg Simvastatin	118	102
ABT-335	119	98
20 mg Simvastatin	119	105
40 mg Simvastatin	116	99
80 mg Simvastatin	59	48

Primary outcome: Mean Percent Change in Triglycerides From Baseline to Final Visit

Time frame: Baseline to 12 Weeks (Final Visit). Mean (Standard Error). Unit: percent change

Measure	ABT-335 + 20 mg Simvastatin n = 113	ABT-335 + 40 mg Simvastatin n = 111	ABT-335 n = 113	20 mg Simvastatin n = 116	40 mg Simvastatin n = 112	80 mg Simvastatin n = 56
Value	-37.4 (2.75)	-42.7 (2.77)	-31.7 (2.74)	-14.2 (2.71)	-22.4 (2.76)	-20.2 (3.82)

ABT-335 + 20 mg Simvastatin vs 20 mg Simvastatin: p <0.001, ANCOVA
ABT-335 + 40 mg Simvastatin vs 40 mg Simvastatin: p <0.001, ANCOVA

Population analysed: All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward

Primary outcome: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit

Time frame: Baseline to 12 Weeks (Final Visit). Mean (Standard Error). Unit: percent change

Measure	ABT-335 + 20 mg Simvastatin n = 105	ABT-335 + 40 mg Simvastatin n = 106	ABT-335 n = 107	20 mg Simvastatin n = 114	40 mg Simvastatin n = 102	80 mg Simvastatin n = 52
Value	17.8 (1.86)	18.9 (1.86)	16.2 (1.85)	7.2 (1.80)	8.5 (1.89)	6.8 (2.61)

ABT-335 + 20 mg Simvastatin vs 20 mg Simvastatin: p <0.001, ANCOVA
ABT-335 + 40 mg Simvastatin vs 40 mg Simvastatin: p <0.001, ANCOVA

Population analysed: All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward

Primary outcome: Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit

Time frame: Baseline to 12 Weeks (Final Visit). Mean (Standard Error). Unit: percent change

Measure	ABT-335 + 20 mg Simvastatin n = 109	ABT-335 + 40 mg Simvastatin n = 108	ABT-335 n = 107	20 mg Simvastatin n = 116	40 mg Simvastatin n = 106	80 mg Simvastatin n = 55
Value	-24.0 (1.94)	-25.3 (1.96)	-4.0 (1.96)	-22.4 (1.90)	-31.7 (1.98)	-40.8 (2.69)

ABT-335 + 20 mg Simvastatin vs ABT-335: p <0.001, ANCOVA
ABT-335 + 40 mg Simvastatin vs ABT-335: p <0.001, ANCOVA

Population analysed: All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT-335 + 20 mg Simvastatin	1 of ?	65 of ?	Not reported
ABT-335 + 40 mg Simvastatin	3 of ?	72 of ?	Not reported
ABT-335	6 of ?	67 of ?	Not reported
20 mg Simvastatin	1 of ?	60 of ?	Not reported
40 mg Simvastatin	1 of ?	65 of ?	Not reported
80 mg Simvastatin	2 of ?	26 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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Active, not recruiting
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Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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?

A Phase 3 study testing ABT-335 and Simvastatin 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 2 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 3 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 (Final Visit)). 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 NCT00300456, which also lists 3 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 3 Jun 2009.