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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00151788
Recruitment Status : Terminated
First Posted : September 9, 2005
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Atherosclerosis Heterozygous Familial Hypercholesterolemia Drug: Pactimibe sulfate Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : February 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006





Primary Outcome Measures :
  1. 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 :
  1. To assess the effects of pactimibe versus placebo, when added to usual medical care:
  2. - on the incidence and the time to first occurrence of
  3. cardiovascular events,
  4. - on inflammatory and oxidative markers, such as serum
  5. high-sensitivity C-reactive protein (hsCRP), plasma
  6. interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
  7. serum nitrotyrosine.
  8. 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.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151788


Locations
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United States, California
Santa Ana, California, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Seattle, Washington, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Chicoutimi, Quebec, Canada
Chomedey Laval, Quebec, Canada
Montreal, Quebec, Canada
Ste-Foy, Quebec, Canada
Israel
Jerusalem, Israel
Netherlands
Amsterdam, Zuidoost, Netherlands
Capelle a/d Ijssel, Netherlands
Dordrecht, Netherlands
Etten-Leur, Netherlands
Goes, Netherlands
Gorinchem, Netherlands
Gouda, Netherlands
Groningen, Netherlands
Hoorn, Netherlands
Leiden, Netherlands
Rotterdam, Netherlands
Tilburg, Netherlands
Norway
Oslo, Norway
South Africa
Bellville, South Africa
Midrand, South Africa
Pretoria, South Africa
Spain
Barcelona, Spain
Cordoba, Spain
Sweden
Linkoping, Sweden
Stockholm, Sweden
United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00151788    
Other Study ID Numbers: 505-205
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Atherosclerosis
Hyperlipoproteinemia Type II
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias