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

NCT00300430 | Completed Phase 3 Results

• 1 other identifier: M05-758
• Study Type: interventional
• Target: 1,911
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

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

  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

  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

  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

  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

  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

  Baseline to Week 52 of the open-label study

Study Arms (3)

A

ACTIVE COMPARATOR

20 mg drug and ABT-335

Drug: ABT-335 and rosuvastatin calcium

B

ACTIVE COMPARATOR

40 mg drug and ABT 335

Drug: ABT-335 and atorvastatin calcium

C

ACTIVE COMPARATOR

40 mg drug and ABT-335

Drug: ABT-335 and simvastatin

Interventions

ABT-335 and rosuvastatin calcium DRUG

ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks

Also known as: ABT-335, TRILIPIX

A

ABT-335 and atorvastatin calcium DRUG

ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks

Also known as: ABT-335, TRILIPIX

B

ABT-335 and simvastatin DRUG

ABT-335 135 mg plus simvastatin daily, 52 weeks

Also known as: ABT-335, TRILIPIX

C

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 one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Global Medical Information

North Chicago, Illinois, 60064, United States

Location

Related Publications (2)

• 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: 22263674 DERIVED

• 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: 18783301 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Coronary Disease

Interventions

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

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Phenols; Ketones; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

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.

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

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 9, 2006
• Study Start: September 1, 2006
• Primary Completion: March 1, 2008
• Last Updated: July 23, 2009
• Results First Posted: July 23, 2009

Record last verified: 2009-06

Locations

US (1)