Back to resultsEfficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.
Primary Purpose
Atherosclerosis, Heterozygous Familial Hypercholesterolemia
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pactimibe sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00151788
First Posted
September 7, 2005
Last Updated
January 16, 2012
Sponsor
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00151788
Brief Title
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
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
5. Study Description
Brief Summary
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Heterozygous Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
796 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pactimibe sulfate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the effects of pactimibe versus placebo, when added to usual medical care:
Title
- on the incidence and the time to first occurrence of
Title
cardiovascular events,
Title
- on inflammatory and oxidative markers, such as serum
Title
high-sensitivity C-reactive protein (hsCRP), plasma
Title
interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
Title
serum nitrotyrosine.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Santa Ana
State/Province
California
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Chicoutimi
State/Province
Quebec
Country
Canada
City
Chomedey Laval
State/Province
Quebec
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Ste-Foy
State/Province
Quebec
Country
Canada
City
Jerusalem
Country
Israel
City
Amsterdam
State/Province
Zuidoost
Country
Netherlands
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
19293413
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.
Results Reference
derived
Learn more about this trial
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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