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Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00585143
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

Condition or disease Intervention/treatment Phase
Dyslipidemia, Renal Insufficiency Drug: ABT-335 Drug: Rosuvastatin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment
Study Start Date : January 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: ABT-335
45 mg once daily for 10 consecutive days
Drug: Rosuvastatin
10 mg once daily for 10 days


Outcome Measures

Primary Outcome Measures :
  1. Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin [ Time Frame: Days 1, 8, 9, and 10 ]

Secondary Outcome Measures :
  1. Safety and tolerability of the study drugs [ Time Frame: Study duration ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Body Mass Index (BMI) 19 to 33, inclusive

Either normal kidney function, or mild or moderate kidney impairment

Exclusion Criteria

Use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management of renal disease.

History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Contacts and Locations

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): NCT00585143


Locations
United States, Florida
Site Reference ID/Investigator# 6610
Gainesville, Florida, United States, 32608
Site Reference ID/Investigator# 6738
Miami, Florida, United States, 33136
United States, Minnesota
Site Reference ID/Investigator# 7723
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Site Reference ID/Investigator# 7319
Knoxville, Tennessee, United States, 37920
United States, Texas
Site Reference ID/Investigator# 6928
San Antonio, Texas, United States, 78209
United States, Virginia
Site Reference ID/Investigator# 8280
Richmond, Virginia, United States, 23298-0160
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00585143     History of Changes
Other Study ID Numbers: M10-070
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by AstraZeneca:
Dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Renal Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors