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NCT01616485 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo

A Phase 1 study, sponsored by VIVUS.

Completed
Registry status
Phase 1
Development phase
106
Enrollment target

NCT01616485: Completed Phase 1 study, sponsored by VIVUS.

NCT01616485 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01616485, a Phase 1 study, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 1
Development phase
106 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.

Primary Outcome

Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.

Interventions

  • DRUG Placebo
  • DRUG TA-1790
  • DRUG Sildenafil citrate
  • DRUG Nitrostat

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2004-03
Est. Completion 2004-05
Phase Phase 1
VIVUS

35 total trials

What the finished NCT01616485 record still lists

NCT01616485 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01616485 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01616485 about?

NCT01616485 is a clinical study titled "Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo". The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.

What is the current status of trial NCT01616485?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2004-03. Estimated completion is 2004-05.

What interventions are being tested in trial NCT01616485?

The interventions under investigation include: Placebo (DRUG), TA-1790 (DRUG), Sildenafil citrate (DRUG), Nitrostat (DRUG).

Who is sponsoring clinical trial NCT01616485?

This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01616485's enrollment target sits among peer trials

106 531st of 2000 higher than 1,468 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01616485, the US trial registry maintained by the National Library of Medicine. NCT01616485 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.