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Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

NCT ID: NCT00751608

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

APL180

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

APL180

Intervention Type DRUG

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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APL180

Intervention Type DRUG

APL180

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis Investigator Site

Other Identifiers

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CAPL180A2207

Identifier Type: -

Identifier Source: org_study_id

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