Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Familial Hypercholesterolemia

Treatments: Drug: APL180; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751608

CAPL180A2207

Details and patient eligibility

About

This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed presence of familial hypercholesterolemia
• Women must be sterilized or post-menopausal

Exclusion criteria

• Smoking an average of greater than 10 cigarettes per day
• History of cardiac events
• Very low or high body weight
• Treatment with fibrates or niacin
• High blood triglyceride levels

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: APL180

Drug: APL180

2

Active Comparator group

Treatment:

Drug: APL180

Drug: APL180

3

Placebo Comparator group

Treatment:

Drug: Placebo