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An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend

NCT ID: NCT00150319

Last Updated: 2008-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-10-31

Brief Summary

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This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

Detailed Description

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The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Conditions

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Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Vfend®; I.V.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate renal insufficiency

Exclusion Criteria

* Active infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Site Status

Pfizer Investigational Site

Knoxville, Tennessee, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501070&StudyName=An+Open%2DLabel+Study+To+Assess+The+Pharmacokinetics%2C+Safety+And+Toleration+Of+Vfend%26%23174%3B+Following+Multiple+Dosing+With+Vfend

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1501070

Identifier Type: -

Identifier Source: org_study_id