A randomized double blind placebo controlled ascending dose study to evaluate the effect of APL180 on endothelial function in patients with familial hypercholesterolemia

A randomized double blind placebo controlled ascending dose study to evaluate the effect of APL180 on endothelial function in patients with familial hypercholesterolemia - APL180

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32563

Enrollment

Registered

2008-08-06

Start date

2008-07-29

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis familial hypercholesterolemia

Interventions

APL180 or placebo infusion APL 180 will be administered in 2 dosages: 1 mg/hour and 6 mg/hour (see page 22 protocol)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Familial hypercholesterolemia age 18-50 yrs informed consent BMI 18-30 kg/m2

Exclusion criteria

Exclusion criteria: smoking previous cardiovascular event diabetes acute inflammatory disease anti-inflammatory medication ECG abnormalities

Design outcomes

Primary

Measure	Time frame
change in endothelial function, assessed as acetylcholine-induced vasodilation in the forearm	—

Secondary

Measure	Time frame
1. side effects 2. APL180 concentration 3. in vitro HDL quality	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)