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NCT00839891 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers

A Phase 1 study of Torsades de Pointes, sponsored by VIVUS.

Completed
Registry status
Phase 1
Development phase
112
Enrollment target
1
Study location

NCT00839891 is a Phase 1 study of Torsades de Pointes that has completed, run by VIVUS. The registered enrollment target is 112 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT00839891, a Phase 1 study of Torsades de Pointes, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 1
Development phase
112 participants
Enrollment target
1
Study location

Study Summary

* Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects. * Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study drugs.

Conditions Studied

Interventions

  • DRUG VI-0521

Study Locations (1)

Arizona

  • MDS Pharma Services - Phoenix

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2009-02
Est. Completion 2009-04
Phase Phase 1

Sponsor

VIVUS

35 total trials

What the Registry Record Tells You About NCT00839891

The ClinicalTrials.gov registry entry for NCT00839891 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Torsades de Pointes appearing as the primary indexed condition, and to 1 intervention - of which VI-0521 is the first listed.

NCT00839891 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT00839891 about?

NCT00839891 is a clinical study titled "A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers". * Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects. * Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study drugs.

What is the current status of trial NCT00839891?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2009-02. Estimated completion is 2009-04.

What conditions does trial NCT00839891 study?

This clinical trial studies the following conditions: Torsades de Pointes.

What interventions are being tested in trial NCT00839891?

The interventions under investigation include: VI-0521 (DRUG).

Who is sponsoring clinical trial NCT00839891?

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

Where is trial NCT00839891 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.