Trial record 1 of 1 for: NCT00195195

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Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

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ClinicalTrials.gov Identifier: NCT00195195

Recruitment Status : Completed

First Posted : September 19, 2005

Last Update Posted : January 31, 2012

Sponsor:

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

First Submitted Date

September 12, 2005

First Posted Date

September 19, 2005

Last Update Posted Date

January 31, 2012

Study Start Date

January 2005

Actual Primary Completion Date

June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

Official Title

A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"

Brief Summary

The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Transplantation patients treated with sirolimus.

Condition

Transplantation

Intervention

Drug: Sirolimus

Transplantation patients treated with sirolimus who consent to participate in the study (register)

Other Name: Rapamune

Study Groups/Cohorts

Sirolimus

Intervention: Drug: Sirolimus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Actual Enrollment

Original Enrollment

200

Actual Study Completion Date

June 2008

Actual Primary Completion Date

June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Transplantation patients treated with sirolimus (Rapamune).

Exclusion Criteria:

Patients must be able to give informed consent.

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Older Adult

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Sweden

Removed Location Countries

Administrative Information

NCT Number

NCT00195195

Other Study ID Numbers

0468-101157

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Wyeth is now a wholly owned subsidiary of Pfizer

Study Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Not Provided

Investigators

Study Director:

Pfizer CT.gov Call Center

Wyeth is now a wholly owned subsidiary of Pfizer

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

January 2012

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