Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

This study has been withdrawn prior to enrollment.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 11, 2008
Last updated: November 4, 2008
Last verified: November 2008
This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.

Condition Intervention Phase
Familial Hypercholesterolemia
Drug: APL180
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in forearm blood flow during each treatment

Estimated Enrollment: 20
Study Start Date: September 2006
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: APL180
Active Comparator: 2 Drug: APL180
Placebo Comparator: 3 Drug: Placebo


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00751608

Sponsors and Collaborators
Novartis Pharmaceuticals
Principal Investigator: Novartis Novartis Investigator Site
  More Information

Responsible Party: External Affairs
ClinicalTrials.gov Identifier: NCT00751608     History of Changes
Other Study ID Numbers: CAPL180A2207 
Study First Received: September 11, 2008
Last Updated: November 4, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on May 24, 2016