Clinical trial NCT00151788: 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.
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Atherosclerosis
Heterozygous Familial Hypercholesterolemia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 796
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: To assess the effects of pactimibe versus placebo, when added to usual medical care:
measure: - on the incidence and the time to first occurrence of
measure: cardiovascular events,
measure: - on inflammatory and oxidative markers, such as serum
measure: high-sensitivity C-reactive protein (hsCRP), plasma
measure: interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
measure: serum nitrotyrosine.
measure: 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.
Other outcomes:
Locations:
city: Santa Ana
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: St. Louis
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Chomedey Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Jerusalem
country: Israel
city: Amsterdam
country: Netherlands
state: Zuidoost
city: Capelle a/d Ijssel
country: Netherlands
city: Dordrecht
country: Netherlands
city: Etten-Leur
country: Netherlands
city: Goes
country: Netherlands
city: Gorinchem
country: Netherlands
city: Gouda
country: Netherlands
city: Groningen
country: Netherlands
city: Hoorn
country: Netherlands
city: Leiden
country: Netherlands
city: Rotterdam
country: Netherlands
city: Tilburg
country: Netherlands
city: Oslo
country: Norway
city: Bellville
country: South Africa
city: Midrand
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Linkoping
country: Sweden
city: Stockholm
country: Sweden
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
References:
citation: Meuwese MC, de Groot E, Duivenvoorden R, Trip MD, Ose L, Maritz FJ, Basart DC, Kastelein JJ, Habib R, Davidson MH, Zwinderman AH, Schwocho LR, Stein EA; CAPTIVATE Investigators. ACAT inhibition and progression of carotid atherosclerosis in patients with familial hypercholesterolemia: the CAPTIVATE randomized trial. JAMA. 2009 Mar 18;301(11):1131-9. doi: 10.1001/jama.301.11.1131.