NCT00300482

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,445

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 25, 2009

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

March 7, 2006

Results QC Date

January 14, 2009

Last Update Submit

June 3, 2009

Conditions

DyslipidemiaCoronary Heart DiseaseMixed Dyslipidemia

Keywords

DyslipidemiaCoronary Heart DiseaseMixed Dyslipidemia

Outcome Measures

Primary Outcomes (3)

  • Mean Percent Change in Triglycerides From Baseline to Final Visit

    \[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100

    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

    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

    Baseline to 12 Weeks

Secondary Outcomes (5)

  • Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit

    Baseline to 12 Weeks

  • Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit

    Baseline to 12 Weeks

  • Mean Percent Change in Total Cholesterol From Baseline to Final Visit

    Baseline to 12 Weeks

  • Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit

    Baseline to 12 Weeks

  • Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit

    Baseline to 12 Weeks

Study Arms (6)

A

ACTIVE COMPARATOR

ABT-335 + 10 mg rosuvastatin

Drug: ABT-335Drug: Rosuvastatin Calcium

B

ACTIVE COMPARATOR

ABT-335 + 20 mg rosuvastatin

Drug: ABT-335Drug: Rosuvastatin Calcium

C

PLACEBO COMPARATOR

ABT-335 monotherapy

Drug: ABT-335Drug: Placebo

D

PLACEBO COMPARATOR

10 mg rosuvastatin monotherapy

Drug: Rosuvastatin CalciumDrug: Placebo

E

PLACEBO COMPARATOR

20 mg rosuvastatin monotherapy

Drug: Rosuvastatin CalciumDrug: Placebo

F

PLACEBO COMPARATOR

40 mg rosuvastatin monotherapy

Drug: Rosuvastatin CalciumDrug: Placebo

Interventions

ABT-335DRUG

135 mg, daily, 12 weeks

ABC
Rosuvastatin CalciumDRUG

Daily, 12 weeks, see Arm Description for dosage information

Also known as: Rosuvastatin
ABDEF
PlaceboDRUG

Daily, 12 weeks, see Arm Description for information regarding placebo type

CDEF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mixed dyslipidemia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information

North Chicago, Illinois, 60064, United States

Location

Related Publications (6)

  • 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.

    PMID: 22263674DERIVED

  • Rosenson 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.

    PMID: 21174145DERIVED

  • 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.

    PMID: 20573750DERIVED

  • 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.

    PMID: 20136164DERIVED

  • Jones 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.

    PMID: 18996523DERIVED

  • 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.

    PMID: 18783301DERIVED

MeSH Terms

Conditions

DyslipidemiasCoronary Disease

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Information Specialist
Organization
Abbott
800-633-9110

Study Officials

  • Maureen Kelly, MD

    Abbott

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2006

Last Updated

June 10, 2009

Results First Posted

March 25, 2009

Record last verified: 2009-06

Locations

US(1)