NCT00795717 (HALO) is a Phase 4 clinical trial of Lovaza in Cardiovascular Disease, sponsored by Tufts University.

Who is sponsoring NCT00795717?

NCT00795717 is sponsored by Tufts University.

What drugs are being tested in NCT00795717?

Interventions in NCT00795717: Lovaza, Placebo.

What condition does NCT00795717 study?

NCT00795717 studies Cardiovascular Disease, HIV Infection.

Is NCT00795717 still recruiting?

NCT00795717 is currently completed. Last updated 30 August 2019.

Are results published for NCT00795717?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-30 · How we verify

NCT00795717: HALO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Completed Phase 4 Results posted Last updated 30 August 2019

What this trial tests

Phase 4 trial testing Lovaza in Cardiovascular Disease in 41 participants. Completed in 1 October 2010.

Timeline

1 July 2008

Primary endpoint
1 October 2010

1 October 2010

Quick facts

Lead sponsor	Tufts University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	41
Start date	1 July 2008
Primary completion	1 October 2010
Estimated completion	1 October 2010
Sites	1 location across United States

Drugs / interventions tested

Lovaza — full drug profile →
Placebo

Conditions studied

Cardiovascular Disease — all drugs for Cardiovascular Disease →
HIV Infection — all drugs for HIV Infection →

Sponsor

Tufts University

Who can join

Adults 18 to 65, any sex, with Cardiovascular Disease or HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Baseline Mean Serum Triglyceride Level at Study End
Time frame: Baseline and 12 weeks
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo

Sponsor's own description

The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Short communication: effects of omega-3 fatty acids on triglycerides and high-density lipoprotein subprofiles in HIV-infected persons with hypertriglyceridemia.
Paranandi A, Asztalos BF, Mangili A, Kuvin J, et al · · 2014 · cited 17× · PMID 24988179 · DOI 10.1089/aid.2014.0005

Verify or expand the search:

Other trials of Lovaza

Trials testing the same drug.

NCT05281562 — Immunonutrition for Diabetic Foot Ulcers · Phase 2, PHASE3 · terminated
NCT04308889 — Pro-Resolving Mediators in Acute Inflammation in Humans · EARLY_PHASE1 · completed

Other recruiting trials for Cardiovascular Disease

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07293260 — Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial · Phase 3 · recruiting
NCT07497932 — Nutritional Effects in Cardiovascular Surgery · NA · recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
NCT06485700 — Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) · NA · recruiting

Other Tufts University trials

Trials by the same sponsor.

NCT07249242 — Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments · NA · recruiting
NCT07099131 — Effective Interventions to Overcome Severe Gag Reflex · EARLY_PHASE1 · not yet recruiting
NCT06428630 — Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus · EARLY_PHASE1 · withdrawn
NCT06526221 — Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India · NA · not yet recruiting
NCT06352645 — Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00795717 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tufts University
Last refreshed: 30 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00795717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing