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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01146522
Other study ID # CLCQ908A2212
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2010
Est. completion date October 2011

Study information

Verified date December 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
LCQ908

Placebo


Locations

Country Name City State
Canada Novartis Investigative Site Quebec

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting and postprandial plasma triglycerides 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 Blood concentration to characterize LCQ908 kinetics serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose
Secondary Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) after 3 weeks of treatment with each dose
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