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COMPLETED Early Phase 1

Treatment of HFpEF With Nitrate Supplement

NCT03289481 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this project is to determine if Neo40, a nitric oxide generating lozenge, when consumed twice daily by subjects with HFpEF, will increase exercise tolerance, decrease symptoms and improve quality of life for patients.

Interventions

  • DRUG Placebo
  • DIETARY_SUPPLEMENT Active lozenge

Study Locations (1)

Maine

  • Penobscot Bay Medical Center — Rockport

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2017-06-29
Est. Completion 2018-08-22
Phase Early Phase 1

Sponsor

MaineHealth

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03289481

The ClinicalTrials.gov registry entry for NCT03289481 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MaineHealth, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Failure With Normal Ejection Fraction appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03289481 reports 1 study location spanning 1 distinct geographic area — top geographies include Maine. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03289481 about?

NCT03289481 is a clinical study titled "Treatment of HFpEF With Nitrate Supplement". The objective of this project is to determine if Neo40, a nitric oxide generating lozenge, when consumed twice daily by subjects with HFpEF, will increase exercise tolerance, decrease symptoms and improve quality of life for patients.

What is the current status of trial NCT03289481?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2017-06-29. Estimated completion is 2018-08-22.

What conditions does trial NCT03289481 study?

This clinical trial studies the following conditions: Heart Failure With Normal Ejection Fraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03289481?

The interventions under investigation include: Placebo (DRUG), Active lozenge (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03289481?

This trial is sponsored by MaineHealth, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03289481 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial