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

Sponsor:	Abbott
Collaborator:	AstraZeneca
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00463606

Purpose

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	Intervention	Phase
Hypercholesterolemia Dyslipidemia	Drug: ABT-335 and Rosuvastatin Calcium Drug: ABT-335 Drug: rosuvastatin calcium	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Calcium Cholesterol

Drug Information available for: Rosuvastatin calcium Rosuvastatin Calcium gluconate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Triglycerides [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
High-density lipoprotein cholesterol (HDL-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Direct low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Non-HDL-C and Very-low density lipoprotein cholesterol (VLDL-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Total Cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Lipoprotein apoB [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
High sensitivity C-reactive protein (hsCRP) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	760
Study Start Date:	April 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ABT-335 and Rosuvastatin Calcium ABT-335 135 mg in combination with rosuvastatin calcium 5 mg	Drug: ABT-335 and Rosuvastatin Calcium ABT-335 135 mg in combination with rosuvastatin calcium 5 mg once daily for 12 weeks
Active Comparator: ABT-335 ABT-335 135 mg monotherapy	Drug: ABT-335 ABT-335 135 mg monotherapy once daily for 12 weeks Other Name: fenofibric acid
Active Comparator: Rosuvastatin Calcium Rosuvastatin calcium 5 mg monotherapy	Drug: rosuvastatin calcium Rosuvastatin calcium 5 mg monotherapy once daily for 12 weeks Other Name: Rosuvastatin

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463606

Show 158 Study Locations

Sponsors and Collaborators

Abbott

AstraZeneca

Investigators

Study Director:

Maureen Kelly, MD

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57.

Roth EM, Rosenson RS, Carlson DM, Fukumoto SM, Setze CM, Blasetto JW, Khurmi NS, Stolzenbach JC, Williams LA. Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):421-8.

Responsible Party:	Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00463606 History of Changes
Other Study ID Numbers:	M06-844
Study First Received:	April 19, 2007
Last Updated:	September 24, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Fenofibric acid
Rosuvastatin
Bone Density Conservation Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012