This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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.

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00151788
First received: September 7, 2005
Last updated: January 16, 2012
Last verified: January 2012
  Purpose
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.

Condition Intervention Phase
Atherosclerosis Heterozygous Familial Hypercholesterolemia Drug: Pactimibe sulfate Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

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.

Estimated Enrollment: 796
Study Start Date: February 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151788

  Show 37 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00151788     History of Changes
Other Study ID Numbers: 505-205
Study First Received: September 7, 2005
Last Updated: January 16, 2012

Additional relevant MeSH terms:
Atherosclerosis
Hypercholesterolemia
Hyperlipoproteinemia Type II
Carotid Artery Diseases
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
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 16, 2017