Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

Phase 3

Completed

• Conditions: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
• Interventions: Drug: ABT-143; Drug: simvastatin

• Registration Number: NCT00812955
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Detailed Description

There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Disposition First Submitted: 2010-08-27
• Disposition First Submitted QC: 2010-09-03
• Disposition First Posted: 2010-09-08
• Results First Submitted: 2012-04-25
• Results First Submitted QC: 2012-06-13
• Results First Posted: 2012-08-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - ABT-143 capsules 5/135 mg	ABT-143	ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
B - ABT-143 capsules 10/135 mg	ABT-143	ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
C - ABT-143 capsules 20/135 mg	ABT-143	ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
D - Simvastatin capsules 40 mg	simvastatin	Simvastatin capsules 40 mg daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)	Baseline to 8 weeks	The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)	Baseline to 8 weeks	The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)	Baseline to 8 weeks	The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

Trial Locations

Locations (129)

Site Reference ID/Investigator# 12654; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 12634; 🇺🇸 Columbiana, Alabama, United States

Site Reference ID/Investigator# 12559; 🇺🇸 Huntsville, Alabama, United States

Site Reference ID/Investigator# 12499; 🇺🇸 Ozark, Alabama, United States

Site Reference ID/Investigator# 12673; 🇺🇸 Chandler, Arizona, United States

Site Reference ID/Investigator# 17282; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 12657; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 12489; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 12495; 🇺🇸 Carmichael, California, United States

Site Reference ID/Investigator# 12467; 🇺🇸 Chula Vista, California, United States

Scroll for more (119 remaining)