Status:
COMPLETED
Exploratory Study of Plaque Regression
Lead Sponsor:
Cerenis Therapeutics, SA
Conditions:
Heterozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective an...
Eligibility Criteria
Inclusion
- Male or Female subjects at least 18 years old
- Subject presents heterozygous FH, known CHD and receiving maximally tolerated lipid modifying therapy, at stable doses for at least 3 months
- LDL-C of \> 110 mg/dl
- Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS
Exclusion
- Confirmed diagnosis of homozygous FH
- Significant health problems (other than cardiovascular disease) in the recent past including blood disorders, cancer, or digestive problems
- Female subjects not meeting the study definition of non child-bearing potential
- Use of an investigational agent within 30 days of the first CER-001 dose
- Receiving current lipid apheresis
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01515241
Start Date
January 1 2012
End Date
May 1 2012
Last Update
March 3 2014
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8