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.

First Received on May 15, 2008. Last Updated on September 26, 2011 History of Changes

Sponsor:	Abbott
Collaborator:	AstraZeneca
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00680017

Purpose

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

Condition	Intervention	Phase
Dyslipidemias Coronary Heart Disease Kidney Disease	Drug: ABT-335 and rosuvastatin Drug: Rosuvastatin	Phase III

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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Kidney Failure

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Rate of change of triglycerides [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of change of HDL-C [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

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 and rosuvastatin Rosuvastatin 5 mg plus ABT-335 45 mg for 8 weeks, then Rosuvastatin 10 mg plus ABT-335 45 mg for 8 weeks	Drug: ABT-335 and rosuvastatin Rosuvastatin 5 mg plus ABT-335 45 mg for 8 weeks, then Rosuvastatin 10 mg plus ABT-335 45 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, ABT-610, Crestor

Eligibility

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

Criteria

Inclusion Criteria

Dyslipidemic subjects with Chronic Kidney Disease Stage 3

Exclusion Criteria

Patients with certain chronic or unstable medical conditions.
Patients with unstable dose of medications or receiving Coumadin, cyclosporine, or certain other medications.
Pregnant or lactating women, or women intending to become pregnant.
Patient with diabetes mellitus that is poorly controlled.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680017

Show 114 Study Locations

Sponsors and Collaborators

Abbott

AstraZeneca

Investigators

Study Director:

Maureen Kelly, MD

Abbott

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00680017 History of Changes
Other Study ID Numbers:	M10-313
Study First Received:	May 15, 2008
Last Updated:	September 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Dyslipidemias
Coronary Heart Disease
Kidney Disease

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Dyslipidemias
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency

Lipid Metabolism Disorders
Metabolic Diseases
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 February 09, 2012