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Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Gothenburg, , SE-413 45 Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Transplantation patients treated with sirolimus (Rapamune).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients must be able to give informed consent.

NCT00195195
Pfizer
Completed
Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

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Descriptive Information
Brief TitleStudy Evaluating Rapamune in Transplant Recipients in the Nordic Countries
Official TitleA Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"
Brief SummaryThe purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationTransplantation patients treated with sirolimus.
ConditionTransplantation
InterventionDrug: Sirolimus
Transplantation patients treated with sirolimus who consent to participate in the study (register)
Other Name: Rapamune
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: January 26, 2012)
66
Original Enrollment
 (submitted: September 12, 2005)
200
Actual Study Completion DateJune 2008
Actual Primary Completion DateJune 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSweden
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195195
Other Study ID Numbers0468-101157
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJanuary 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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