Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood - Full Text View

Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood (FIRST)

This study is currently recruiting participants.

Verified by Abbott, December 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00616772

Purpose

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain), in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol"), after taking atorvastatin.

Condition	Intervention	Phase
Dyslipidemias Carotid Artery Disease Coronary Heart Disease	Drug: ABT-335 Drug: Placebo	Phase III

MedlinePlus related topics: Carotid Artery Disease Coronary Artery Disease Heart Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Abbott:

Primary Outcome Measures:

Rate of change of cIMT [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	February 2008
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ABT 335: Experimental	Drug: ABT-335 one daily for 2 years
Placebo: Placebo Comparator	Drug: Placebo one daily for 2 years

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with mixed dyslipidemia.
Qualifying cIMT thickness.

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.
Patients with diabetes mellitus that is poorly controlled.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616772

Contacts

Contact: Debra Schuerr, BS

847-937-5748

debra.m.schuerr@abbott.com

Show 82 Study Locations

Sponsors and Collaborators

Abbott

More Information

Responsible Party:	Abbott ( Laura A Williams, MD, MPH )
Study ID Numbers:	M10-158
Study First Received:	February 5, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00616772
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Central Nervous System Diseases
Ischemia
Arteriosclerosis
Brain Diseases

Cerebrovascular Disorders
Coronary Disease
Metabolic disorder
Carotid Artery Diseases
Atorvastatin
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009