Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03398005
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-11-21
Brief Title:
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides TRILOGY 1
Sponsor:
Acasti Pharma Inc
Organization:
Acasti Pharma Inc
Study Overview
Official Title:
A Phase 3 Multi-center Placebo-controlled Randomized Double-blind 26-week Study to Assess the Safety and Efficacy of CaPre in Patients With Severe Hypertriglyceridemia
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRILOGY 1
Brief Summary:
The primary objective of this study is to determine the efficacy of CaPre 4 g daily compared to placebo in lowering fasting triglyceride TG levels in patients with fasting TG levels 500 mgdL and 1500 mgdL 57 mmolL and 170 mmolL after 12 weeks of treatment
Approximately 615 subjects will be screened to obtain 245 randomized subjects following a 251 treatment allocation ratio CaPre placebo
Approximately 615 subjects will be screened to obtain 245 randomized subjects following a 251 treatment allocation ratio CaPre placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None