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Long-Term Safety Of PF-00547659 In Ulcerative Colitis

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Mayo Clinic Arizona - Scottsdale
Scottsdale, Arizona, 85259 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects between 18 and 66 years of age.

- Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the
84 day (12 week) induction period.

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

- Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced
serious event(s) related to the investigational product, an unstable medical
condition, or any other reason, in the opinion of the investigator, would preclude
entry or participation in this study.

- Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or
Methotrexate (MTX).

NCT01771809
Pfizer
Active, not recruiting
Long-Term Safety Of PF-00547659 In Ulcerative Colitis

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Pfizer Clinical Trials Contact Center

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[email protected]

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Not Provided
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
December 2017
July 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects between 18 and 66 years of age.
  • Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
  • Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
Sexes Eligible for Study: All
18 Years to 66 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   United States
Switzerland
 
NCT01771809
A7281010
2012-002031-28 ( EudraCT Number )
TURANDOT II ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Shire
Shire
Not Provided
Study Director: Shire Physician Shire
Shire
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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