A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidemia
• Interventions: Drug: ABT-335; Drug: rosuvastatin calcium; Drug: ABT-335 and rosuvastatin calcium

• Registration Number: NCT00463606
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Detailed Description

There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Disposition First Submitted: 2010-08-27
• Disposition First Submitted QC: 2010-09-13
• Disposition First Posted: 2010-09-15
• 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: 760

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-335	ABT-335	ABT-335 135mg monotherapy administered orally, once daily for 12 weeks
Rosuvastatin Calcium	rosuvastatin calcium	Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks
ABT-335 and Rosuvastatin Calcium	ABT-335 and rosuvastatin calcium	ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)	Baseline to 12 Weeks	The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)	Baseline to 12 Weeks	The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Trial Locations

Locations (168)

Site Reference ID/Investigator# 5469; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 4428; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 4985; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 4493; 🇺🇸 Huntsville, Alabama, United States

Site Reference ID/Investigator# 4510; 🇺🇸 Huntsville, Alabama, United States

Site Reference ID/Investigator# 4431; 🇺🇸 Ozark, Alabama, United States

Site Reference ID/Investigator# 4519; 🇺🇸 Tuscaloosa, Alabama, United States

Site Reference ID/Investigator# 4395; 🇺🇸 Chandler, Arizona, United States

Site Reference ID/Investigator# 4483; 🇺🇸 Gilbert, Arizona, United States

Site Reference ID/Investigator# 4411; 🇺🇸 Scottsdale, Arizona, United States

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