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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Daiichi Sankyo

Status and phase

Terminated
Phase 3
Phase 2

Conditions

Heterozygous Familial Hypercholesterolemia
Atherosclerosis

Treatments

Drug: Pactimibe sulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151788
505-205

Details and patient eligibility

About

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

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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