Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE. - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00151788

Purpose

The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.

Condition	Intervention	Phase
Atherosclerosis Heterozygous Familial Hypercholesterolemia	Drug: Pactimibe sulfate	Phase II Phase III

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Carotid Artery Disease Cholesterol Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Stratified, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Heterozygous Familial Hypercholesterolemia and Carotid Atherosclerosis Using Carotid Ultrasound (CUS)

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.

Secondary Outcome Measures:

To assess the effects of pactimibe versus placebo, when added to usual medical care:
- on the incidence and the time to first occurrence of
cardiovascular events,
- on inflammatory and oxidative markers, such as serum
high-sensitivity C-reactive protein (hsCRP), plasma
interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
serum nitrotyrosine.
To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events.

Estimated Enrollment:	796
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of heterozygous familial hypercholesterolemia
Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects
Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy

Exclusion Criteria:

Breast feeding or lactating women
Previous organ transplantation
High-grade stenosis (>75%) or the occlusion of any segment of either carotid artery
History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151788

Show 37 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Study ID Numbers:	505-205
Study First Received:	September 7, 2005
Last Updated:	December 16, 2005
ClinicalTrials.gov Identifier:	NCT00151788
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Atherosclerosis
Arterial Occlusive Diseases
Hypercholesterolemia, autosomal dominant
Metabolic Diseases
Hyperlipidemias
Hyperlipoproteinemia Type II
Disease Progression
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis

Brain Diseases
Cerebrovascular Disorders
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic disorder
Carotid Artery Diseases
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009