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Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01146522
First received: June 9, 2010
Last updated: December 28, 2012
Last verified: December 2012
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Purpose
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
| Condition | Intervention | Phase |
|---|---|---|
| Hyperlipoproteinemia | Drug: LCQ908 Drug: Placebo | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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) |
Resource links provided by NLM:
Further study details as provided by Novartis ( Novartis Pharmaceuticals ):
Primary Outcome Measures:
- 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:
- 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 ]
- Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) [ Time Frame: after 3 weeks of treatment with each dose ]
| Enrollment: | 8 |
| Study Start Date: | May 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LCQ908 | Drug: LCQ908 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01146522
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146522
Locations
| Canada | |
| Novartis Investigative Site | |
| Quebec, Canada | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01146522 History of Changes |
| Other Study ID Numbers: |
CLCQ908A2212 |
| Study First Received: | June 9, 2010 |
| Last Updated: | December 28, 2012 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
Familial hyperchylomicronemia Lipoprotein lipase deficiency Hyperlipoproteinemia Triglycerides |
Hypertriglyceridemia LCQ908 Hyperlipoproteinemia associated with lipoprotein lipase deficiency |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Hyperlipoproteinemias Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on July 17, 2017