NCT00751608

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

September 11, 2008

Last Update Submit

September 22, 2016

Conditions

Familial Hypercholesterolemia

Keywords

Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation

Outcome Measures

Primary Outcomes (1)

  • Change in forearm blood flow during each treatment

Study Arms (3)

1

EXPERIMENTAL
Drug: APL180

2

ACTIVE COMPARATOR
Drug: APL180

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

APL180DRUG
1
PlaceboDRUG
3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis

    Novartis Investigator Site

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 23, 2016

Record last verified: 2016-09