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Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00751608
First received: September 11, 2008
Last updated: November 4, 2008
Last verified: November 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on May 22, 2013