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Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

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ClinicalTrials.gov Identifier: NCT00751608
Recruitment Status : Withdrawn
First Posted : September 12, 2008
Last Update Posted : September 23, 2016
Sponsor:
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Familial Hypercholesterolemia Drug: APL180 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: APL180
Active Comparator: 2 Drug: APL180
Placebo Comparator: 3 Drug: Placebo



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751608


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

Responsible Party: External Affairs
ClinicalTrials.gov Identifier: NCT00751608     History of Changes
Other Study ID Numbers: CAPL180A2207
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

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