Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

Phase 2

Withdrawn

• Conditions: Familial Hypercholesterolemia
• Interventions: Drug: APL180; Drug: Placebo

• Registration Number: NCT00751608
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	APL180	-
3	Placebo	-
1	APL180	-

Primary Outcome Measures

Name	Time	Method
Change in forearm blood flow during each treatment