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

Verified by: Abbott, September 2010
First Received: April 19, 2007 | Last Updated: September 24, 2010 | Phase: Phase 3 | Start Date: April 2007
Overall Status: Completed | Estimated Enrollment: 760
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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...

Brief Summary

Official Title: “A 12-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

  • Drug: ABT-335 and Rosuvastatin Calcium
    • ABT-335 135 mg in combination with rosuvastatin calcium 5 mg once daily for 12 weeks
  • Drug: ABT-335
    • ABT-335 135 mg monotherapy once daily for 12 weeks
  • Drug: rosuvastatin calcium
    • Rosuvastatin calcium 5 mg monotherapy once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: ABT-335 and Rosuvastatin Calcium
    • ABT-335 135 mg in combination with rosuvastatin calcium 5 mg
  • Active Comparator: ABT-335
    • ABT-335 135 mg monotherapy
  • Active Comparator: Rosuvastatin Calcium
    • Rosuvastatin calcium 5 mg monotherapy

Outcome Measures for this Clinical Trial

Primary Measures

  • Triglycerides
    • Time Frame: 12 Weeks
      Safety Issue?: No
  • High-density lipoprotein cholesterol (HDL-C)
    • Time Frame: 12 Weeks
      Safety Issue?: No
  • Direct low-density lipoprotein cholesterol (LDL-C)
    • Time Frame: 12 Weeks
      Safety Issue?: No

Secondary Measures

  • Non-HDL-C and Very-low density lipoprotein cholesterol (VLDL-C)
    • Time Frame: 12 Weeks
      Safety Issue?: No
  • Total Cholesterol
    • Time Frame: 12 Weeks
      Safety Issue?: No
  • Lipoprotein apoB
    • Time Frame: 12 Weeks
      Safety Issue?: No
  • High sensitivity C-reactive protein (hsCRP)
    • Time Frame: 12 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Adult male and female subjects who voluntarily sign the informed consent and meet the lipid inclusion criteria for dyslipidemia.
  • Subject is >= 18 years of age at the time of the Pre-screening Visit.
  • Subjects must agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

Exclusion Criteria:

  • Subjects with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or subjects who are taking excluded concomitant medications are not allowed in the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Maureen Kelly, MD Study Director Abbott  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00463606

Study ID Number: M06-844

ClinicalTrials.gov Identifier: NCT00463606

Health Authority: United States: Food and Drug Administration

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