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NCT00360217 · ClinicalTrials.gov registry record · NA

The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes

A NA study of Diabetes and Coronary Artery Disease, sponsored by Maine Center for Lipids and Cardiovascular Health.

Completed
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT00360217 is a NA study of Diabetes and Coronary Artery Disease that has completed, run by Maine Center for Lipids and Cardiovascular Health. The registered enrollment target is 60 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00360217, a NA study of Diabetes and Coronary Artery Disease, has completed, sponsored by Maine Center for Lipids and Cardiovascular Health.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease, stroke or diabetes). The rationale for the study is based around the finding that patients with CAD have an approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is one of the ingredients in fish oil). In studies of statin-based therapies, it has been observed that statins reduce the risk of coronary events 20-45%. There has not yet been research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in patient treatment either to reduce recurrent cardiac events or to address another reported finding of fish oils to lower triglyceride levels (triglyceride is a form of "blood fat"). This research project will be a pilot project to assess the safety and effectiveness of DHA "add-on" therapy in patients currently being treated with statins for CAD. The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower triglyceride levels in the blood. This is a double-blinded randomized clinical trial.

Interventions

  • DRUG docosahexanoic acid (DHA)

Study Locations (1)

Maine

  • Maine Center for Lipids and Cardiovascular Health - Scarborough

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2006-01
Est. Completion 2007-05
Phase NA

What the Registry Record Tells You About NCT00360217

The ClinicalTrials.gov registry entry for NCT00360217 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is Maine Center for Lipids and Cardiovascular Health, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which docosahexanoic acid (DHA) is the first listed.

NCT00360217 reports 1 study location spanning 1 distinct geographic area - top geographies include Maine.

Frequently Asked Questions

What is clinical trial NCT00360217 about?

NCT00360217 is a clinical study titled "The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes". This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary arter...

What is the current status of trial NCT00360217?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2006-01. Estimated completion is 2007-05.

What conditions does trial NCT00360217 study?

This clinical trial studies the following conditions: Diabetes, Coronary Artery Disease, Hyperlipidemia, Hypertriglyceridemia (TG>200<500), Coronary Risk Equivalent.

What interventions are being tested in trial NCT00360217?

The interventions under investigation include: docosahexanoic acid (DHA) (DRUG).

Who is sponsoring clinical trial NCT00360217?

This trial is sponsored by Maine Center for Lipids and Cardiovascular Health, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00360217 being conducted?

This trial has 1 study location across Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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