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NCT01408303 · ClinicalTrials.gov registry record · Phase 3
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
A Phase 3 study of Cardiovascular Disease and Hypertriglyceridemia, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 646
- Enrollment target
- 20
- Study locations
NCT01408303: Completed Phase 3 study of Cardiovascular Disease and Hypertriglyceridemia, sponsored by AstraZeneca.
NCT01408303 is a Phase 3 study of Cardiovascular Disease and Hypertriglyceridemia that has completed, run by AstraZeneca. The registered enrollment target is 646 participants, below the 2,693-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408303, a Phase 3 study of Cardiovascular Disease and Hypertriglyceridemia, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 646 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.
Primary Outcome
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.
Conditions Studied
Interventions
- DRUG Olive oil, 4g
- DRUG omega-3-carboxylic acids, 2g
- DRUG omega-3-carboxylic acids, 4g
Study Locations (20)
California
- - Encinitas
- - Lomita
- - Los Angeles
- - Sacramento
- - San Diego
- - Spring Valley
- - Westlake Village
Florida
- - Brandon
- - Clearwater
- - Coral Gables
- - Hialeah
- - Jacksonville
- - Jacksonville
- - Jupiter
Arizona
- - Chandler
- - Phoenix
Colorado
- - Colorado Springs
- - Denver
Alabama
- - Muscle Shoals
Arkansas
- - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01408303 record still lists
NCT01408303 is an interventional study that assigns participants to a tested intervention. The registered 646 participants enrollment target is mid-sized for trials with a published cap, below the 2,693-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 3 interventions - of which Olive oil, 4g is the first listed.
NCT01408303 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01408303 about?
NCT01408303 is a clinical study titled "[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL". The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.
What is the current status of trial NCT01408303?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 646 participants. The study started on 2011-08. Estimated completion is 2012-06.
What conditions does trial NCT01408303 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Hypertriglyceridemia.
What interventions are being tested in trial NCT01408303?
The interventions under investigation include: Olive oil, 4g (DRUG), omega-3-carboxylic acids, 2g (DRUG), omega-3-carboxylic acids, 4g (DRUG).
Who is sponsoring clinical trial NCT01408303?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01408303 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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646 31st of 137 higher than 107 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
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