An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend
Official Title ICMJE
An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend®; I.V. In Subjects With Moderately Impaired Renal Function
This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency
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.
Study Type ICMJE
Study Phase ICMJE
Phase 1 Phase 2
Study Design ICMJE
Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label)
Drug: Vfend®; I.V.
Study Arms ICMJE
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Status ICMJE
Actual Enrollment ICMJE (submitted: September 25, 2008)
Original Enrollment ICMJE (submitted: September 6, 2005)
Actual Study Completion Date ICMJE
Actual Primary Completion Date
October 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Patients with moderate renal insufficiency
Sexes Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers ICMJE
Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE
Removed Location Countries
NCT Number ICMJE
Other Study ID Numbers ICMJE
Has Data Monitoring Committee
U.S. FDA-regulated Product
IPD Sharing Statement ICMJE
Director, Clinical Trial Disclosure Group, Pfizer, Inc.