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

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300456
• Other study ID #: M05-749
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: May 29, 2009
• Start date: March 2006

Study information

• Verified date: May 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with mixed dyslipidemia

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dyslipidemia
• Dyslipidemias
• Heart Diseases
• Mixed Dyslipidemia
• Myocardial Ischemia

Intervention

Drug:
• ABT-335
135 mg, daily, 12 weeks
• Simvastatin
daily, 12 weeks, see Arm Description for dosage information
• Placebo
Daily, 12 weeks, see Arm Description for placebo information

Locations

Country	Name	City	State
United States	Global Medical Information	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Triglycerides From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Primary	Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Primary	Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Secondary	Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Secondary	Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Secondary	Mean Percent Change in Total Cholesterol From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Secondary	Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No
Secondary	Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit		Baseline to 12 Weeks (Final Visit)	No