Status:
COMPLETED
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hyperlipoproteinemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01146522
Start Date
May 1 2010
End Date
October 1 2011
Last Update
December 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Québec, Canada