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

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ClinicalTrials.gov Identifier: NCT00463606
Recruitment Status : Completed
First Posted : April 20, 2007
Results First Posted : August 1, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemia Drug: ABT-335 and rosuvastatin calcium Drug: ABT-335 Drug: rosuvastatin calcium Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: ABT-335 and Rosuvastatin Calcium
ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks
Drug: ABT-335 and rosuvastatin calcium
ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
Other Name: ABT-335 / Rosuvastatin Combination (ABT-143)

Active Comparator: ABT-335
ABT-335 135mg monotherapy administered orally, once daily for 12 weeks
Drug: ABT-335
ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Other Name: fenofibric acid

Active Comparator: Rosuvastatin Calcium
Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks
Drug: rosuvastatin calcium
Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Other Name: Rosuvastatin




Primary Outcome Measures :
  1. Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) [ Time Frame: 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.

  2. Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) [ Time Frame: 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.

  3. Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) [ Time Frame: 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 :
  1. 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) [ Time Frame: 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.

  2. 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) [ Time Frame: 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.

  3. Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) [ Time Frame: 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.

  4. Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) [ Time Frame: 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.

  5. Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) [ Time Frame: 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.

  6. Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Adult male and female participants who voluntarily sign the informed consent.
  • Fasting lipid results following greater than 12-hour fasting period:

    • Triglycerides level greater than or equal to 150 mg/dL,
    • High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
    • Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.
  • Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

  • Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.
  • Participants receiving coumarin anticoagulants or systemic cyclosporine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463606


  Show 168 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00463606     History of Changes
Other Study ID Numbers: M06-844
First Posted: April 20, 2007    Key Record Dates
Results First Posted: August 1, 2012
Last Update Posted: October 3, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Rosuvastatin Calcium
Fenofibric acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors