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NCT00113009 · ClinicalTrials.gov registry record · Phase 2

Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

A Phase 2 study of Peripheral Vascular Disease, sponsored by Valentis.

Completed
Registry status
Phase 2
Development phase
148
Enrollment target
20
Study locations

NCT00113009 is a Phase 2 study of Peripheral Vascular Disease that has completed, run by Valentis. The registered enrollment target is 148 participants, below the 276-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00113009, a Phase 2 study of Peripheral Vascular Disease, has completed, sponsored by Valentis.

COMPLETED
Registry status
Phase 2
Development phase
148 participants
Enrollment target
20
Study locations

Study Summary

This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Conditions Studied

Peripheral Vascular Disease

Interventions

  • DRUG VLTS-934

Study Locations (20)

Florida

  • - Deerfield Beach
  • - DeLand
  • - Jacksonville
  • - Melbourne
  • - Sarasota

California

  • - Beverly Hills
  • - Los Angeles
  • - Mountain View
  • - Santa Rosa

Louisiana

  • - Houma
  • - Thibodaux

Michigan

  • University of Michigan Health Systems - Ann Arbor
  • - Flint

Alabama

  • - Birmingham

Georgia

  • - Atlanta

Illinois

  • - Chicago

Maine

  • - Auburn

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2005-03
Est. Completion 2006-07
Phase Phase 2

Sponsor

Valentis

2 total trials

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What the Registry Record Tells You About NCT00113009

The ClinicalTrials.gov registry entry for NCT00113009 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (46% lower). The listed sponsor is Valentis, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 1 intervention - of which VLTS-934 is the first listed.

NCT00113009 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Louisiana.

Frequently Asked Questions

What is clinical trial NCT00113009 about?

NCT00113009 is a clinical study titled "Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease". This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscula...

What is the current status of trial NCT00113009?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2005-03. Estimated completion is 2006-07.

What conditions does trial NCT00113009 study?

This clinical trial studies the following conditions: Peripheral Vascular Disease.

What interventions are being tested in trial NCT00113009?

The interventions under investigation include: VLTS-934 (DRUG).

Who is sponsoring clinical trial NCT00113009?

This trial is sponsored by Valentis, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00113009 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.