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NCT01594983 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT01594983: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01594983 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01594983, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
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.
Primary Outcome
The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.
Interventions
- DRUG Fenofibrate
- DRUG Fish Oil
- DRUG LCQ908
- DRUG Placebo of LCQ908
- DRUG Placebo of fenofibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
What the finished NCT01594983 record still lists
NCT01594983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 5 interventions - of which Fenofibrate is the first listed.
NCT01594983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01594983 about?
NCT01594983 is a clinical study titled "A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia". 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.
What is the current status of trial NCT01594983?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2012-06. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01594983?
The interventions under investigation include: Fenofibrate (DRUG), Fish Oil (DRUG), LCQ908 (DRUG), Placebo of LCQ908 (DRUG), Placebo of fenofibrate (DRUG).
Who is sponsoring clinical trial NCT01594983?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01594983's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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