A randomized double blind placebo controlled ascending dose study to evaluate the effect of APL180 on endothelial function in patients with familial hypercholesterolemia
Phase 2
- Conditions
- atherosclerosisfamilial hypercholesterolemia10003216
- Registration Number
- NL-OMON32563
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Familial hypercholesterolemia
age 18-50 yrs
informed consent
BMI 18-30 kg/m2
Exclusion Criteria
smoking
previous cardiovascular event
diabetes
acute inflammatory disease
anti-inflammatory medication
ECG abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>change in endothelial function, assessed as acetylcholine-induced vasodilation<br /><br>in the forearm</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. side effects<br /><br>2. APL180 concentration<br /><br>3. in vitro HDL quality</p><br>