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Trial record 1 of 1 for:    NCT00195195
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Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 1
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
 (submitted: January 26, 2012)
66
Original Enrollment
 (submitted: September 12, 2005)
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 No
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 No
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