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
Endpoint Classification: Safety/Efficacy Study
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
Genders Eligible for Study:   Both
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

No publications provided by Daiichi Sankyo Inc.

Additional 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Carotid Artery Diseases
Hypercholesterolemia
Hyperlipoproteinemia Type II
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014