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

Sponsors and Collaborators:	Abbott 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	Other: ABT-335 and Rosuvastatin Combination Drug: ABT-335 Drug: rosuvastatin calcium	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Calcium Cholesterol

Drug Information available for: Rosuvastatin Rosuvastatin calcium Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:

Triglycerides [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
HDL-C [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Direct LDL-C [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Non-HDL-C and VLDL [ 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
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ABT-335 and Rosuvastatin Calcium: Active Comparator ABT-335 135mg in combination with rosuvastatin calcium 5mg QD	Other: ABT-335 and Rosuvastatin Combination 12 Weeks, see Arm for intervention description
ABT-335: Placebo Comparator ABT-335 135mg monotherapy QD	Drug: ABT-335 12 Weeks, see Arm for intervention description
Rosuvastatin Calcium: Placebo Comparator Rosuvastatin calcium 5mg monotherapy QD	Drug: rosuvastatin calcium 12 Weeks, see Arm for intervention description

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 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

More Information

Responsible Party:	Abbott ( Dawn Carlson, MD, MPH, FCCP )
Study ID Numbers:	M06-844
Study First Received:	April 19, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00463606
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Fenofibric acid

Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009