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30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00680017
First received: May 15, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.


Condition Intervention Phase
Dyslipidemia
Kidney Disease
 Drug: ABT-335 plus rosuvastatin
Drug: Rosuvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Median Percent Change in Triglycerides From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Triglycerides were measured in milligrams/deciliter.


Secondary Outcome Measures:
  • Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).


Enrollment: 280
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-335 plus rosuvastatin
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
 Drug: ABT-335 plus rosuvastatin
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Other Name: fenofibric acid and rosuvastatin
Active Comparator: Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
 Drug: Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Other Name: rosuvastatin, Crestor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Dyslipidemic participants with Chronic Kidney Disease Stage 3

  • For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]):

    • Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).
    • Fasting lipid results following greater than or equal to 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 Exclusion Criteria
  • Participants with certain chronic or unstable medical conditions.
  • Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.
  • Pregnant or lactating women, or women intending to become pregnant.
  • Participants with diabetes mellitus that is poorly controlled.
  • Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680017

  Show 114 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00680017     History of Changes
Other Study ID Numbers: M10-313
Study First Received: May 15, 2008
Results First Received: April 25, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Dyslipidemia
Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Dyslipidemias
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Fenofibric acid
Rosuvastatin
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013