A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

NCT00491530 | Completed Phase 3 Results

• 1 other identifier: M06-884
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study

  All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.

  Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.

Secondary Outcomes (6)

• Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study

  Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)

• Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study

  Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)

• Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study

  Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)

• Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study

  Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)

• Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study

  Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)

Study Arms (3)

ABT-335 + rosuvastatin calcium

EXPERIMENTAL

Drug: ABT-335; Drug: rosuvastatin calcium

ABT-335 + simvastatin

EXPERIMENTAL

Drug: ABT-335; Drug: simvastatin

ABT-335 + atorvastatin calcium

EXPERIMENTAL

Drug: ABT-335; Drug: atorvastatin calcium

Interventions

ABT-335 DRUG

Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

Also known as: fenofibric acid

ABT-335 + atorvastatin calcium; ABT-335 + rosuvastatin calcium; ABT-335 + simvastatin

rosuvastatin calcium DRUG

Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

Also known as: Crestor

ABT-335 + rosuvastatin calcium

simvastatin DRUG

Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

Also known as: Zocor

ABT-335 + simvastatin

atorvastatin calcium DRUG

Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

Also known as: Lipitor

ABT-335 + atorvastatin calcium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female subjects who voluntarily sign the informed consent.
• Subject has successfully completed the treatment phase of the preceding open-label year 1 study.

You may not qualify if:

• Subject is using or will use investigational medications, except as approved by Abbott.
• Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Medical Information Specialist

Abbott Park, Illinois, 60064, United States

Location

Related Publications (1)

• Kipnes MS, Roth EM, Rhyne JM, Setze CM, Lele A, Kelly MT, Sleep DJ, Stolzenbach JC. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig. 2010;30(1):51-61. doi: 10.2165/11319800-000000000-00000.

  PMID: 19995098 DERIVED

MeSH Terms

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid; fenofibric acid; Rosuvastatin Calcium; Simvastatin; Atorvastatin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

This was an open-label study designed to assess the long-term safety of the combination therapies. Evaluation of efficacy outcomes was a secondary objective.

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

800-633-9110

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 20, 2012
• Results First Posted: December 7, 2009

Record last verified: 2012-01

Locations

US (1)