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

NCT00300469 | Completed Phase 3 Results

• 1 other identifier: M05-750
• Study Type: interventional
• Target: 613
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.

Conditions

Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia

Keywords

Mixed Dyslipidemia; Coronary Heart Disease; 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 (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

  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

  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

  Baseline to 12 Weeks (Final Visit)

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

  Baseline to 12 Weeks (Final Visit)

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

  Baseline to 12 Weeks (Final Visit)

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

  Baseline to 12 Weeks (Final Visit)

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

  Baseline to 12 Weeks (Final Visit)

Study Arms (6)

A

ACTIVE COMPARATOR

ABT-335 + 20 mg atorvastatin

Drug: ABT-335; Drug: Atorvastatin

B

ACTIVE COMPARATOR

ABT-335 + 40 mg atorvastatin

Drug: ABT-335; Drug: Atorvastatin

C

PLACEBO COMPARATOR

ABT-335 monotherapy

Drug: ABT-335; Drug: Placebo

D

PLACEBO COMPARATOR

20 mg atorvastatin monotherapy

Drug: Atorvastatin; Drug: Placebo

E

PLACEBO COMPARATOR

40 mg atorvastatin monotherapy

Drug: Atorvastatin; Drug: Placebo

F

PLACEBO COMPARATOR

80 mg atorvastatin monotherapy

Drug: Atorvastatin; Drug: Placebo

Interventions

ABT-335 DRUG

135 mg, daily, 12 weeks

A; B; C

Atorvastatin DRUG

Daily, 12 weeks, see Arm Description for dosage information

A; B; D; E; F

Placebo DRUG

daily, 12 weeks, see Arm Description for placebo information

C; D; E; F

Eligibility Criteria

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

You may qualify if:

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

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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Global Medical Information

North Chicago, Illinois, 60064, United States

Location

Related Publications (3)

• 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: 20573750 DERIVED

• 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: 20136164 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

Coronary Disease; Dyslipidemias

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid; Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

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: 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: February 1, 2007
• Last Updated: June 3, 2009
• Results First Posted: March 25, 2009

Record last verified: 2009-06

Locations

US (1)