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Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01146522
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : January 1, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.

Condition or disease Intervention/treatment Phase
Hyperlipoproteinemia Drug: LCQ908 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)
Study Start Date : May 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: LCQ908 Drug: LCQ908
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Fasting and postprandial plasma triglycerides [ Time Frame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment) ]

Secondary Outcome Measures :
  1. Blood concentration to characterize LCQ908 kinetics [ Time Frame: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose ]
  2. Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) [ Time Frame: after 3 weeks of treatment with each dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
  • Non breast feeding women.
  • Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.

Exclusion Criteria:

Patients with:

  • uncontrolled type 1 or type 2 diabetes mellitus,
  • active pancreatitis (the month prior to study start),
  • history of drug or alcohol abuse within the 12 months prior to dosing,
  • or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

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 identifier (NCT number): NCT01146522

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Novartis Investigative Site
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01146522    
Other Study ID Numbers: CLCQ908A2212
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: January 1, 2013
Last Verified: December 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Familial hyperchylomicronemia
Lipoprotein lipase deficiency
Hyperlipoproteinemia associated with lipoprotein lipase deficiency
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases