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A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

NCT01594983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-12-17

No results posted yet for this study

Summary

This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.

Conditions

  • Non Familial Chylocmicronemia Syndrome (Non-FCS)

Interventions

DRUG

LCQ908

DRUG

Fenofibrate

Fenofibrate once daily 12 weeks

DRUG

Fish Oil

Fish Oil once daily for 12 weeks

DRUG

Placebo of LCQ908

Matching placebo of LCQ908

DRUG

Placebo of fenofibrate

Matching placebo of fenofibrate

DRUG

Placebo of fish oil

Matching placebo of fish oil capsule

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States
  • Canada
  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01594983 on ClinicalTrials.gov