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NCT00430716 · ClinicalTrials.gov registry record · Phase 4

To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Terminated
Registry status
Phase 4
Development phase
130
Enrollment target

NCT00430716: Clinical Trial Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

NCT00430716 is a Phase 4 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 130 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00430716, a Phase 4 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

TERMINATED
Registry status
Phase 4
Development phase
130 participants
Enrollment target

Study Summary

To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

Primary Outcome

6 MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.

Interventions

  • DRUG Sildenafil citrate

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2008-04-08
Est. Completion 2010-05-25
Phase Phase 4

Why NCT00430716 stopped before completion

NCT00430716 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Sildenafil citrate is the first listed.

NCT00430716 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00430716 about?

NCT00430716 is a clinical study titled "To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.". To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

What is the current status of trial NCT00430716?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2008-04-08. Estimated completion is 2010-05-25.

What interventions are being tested in trial NCT00430716?

The interventions under investigation include: Sildenafil citrate (DRUG).

Who is sponsoring clinical trial NCT00430716?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00430716's enrollment target sits among peer trials

130 622nd of 2000 higher than 1,370 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00430716, the US trial registry maintained by the National Library of Medicine. NCT00430716 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.