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.
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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 |
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Recruitment Status :
Terminated
First Posted : September 9, 2005
Last Update Posted : January 18, 2012
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Sponsor:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial hypercholesterolemia
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.
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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
| 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):
| 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 |