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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ClinicalTrials.gov Identifier: NCT00151788 |
Recruitment Status :
Terminated
First Posted : September 9, 2005
Last Update Posted : January 18, 2012
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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 |

- 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.
- 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 |
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

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
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 |
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 |
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 |