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Arimidex in McCune Albright Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00055302
First Posted: February 26, 2003
Last Update Posted: September 1, 2015
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.
Information provided by (Responsible Party):
AstraZeneca
February 25, 2003
February 26, 2003
September 1, 2015
August 2002
February 2006   (Final data collection date for primary outcome measure)
The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity [ Time Frame: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal ]
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Complete list of historical versions of study NCT00055302 on ClinicalTrials.gov Archive Site
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Arimidex in McCune Albright Syndrome
An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
McCune-Albright Syndrome
Drug: Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth
Experimental: 1
Intervention: Drug: Arimidex 1 mg
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2015
February 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
  • females less than or equal to 10 years of age
  • diagnosed with McCune-Albright Syndrome
  • have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

  • any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
  • concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
  • liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age
  • known hypersensitivity to any component of study medication
Sexes Eligible for Study: Female
up to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   United Kingdom
Spain,   United States
 
NCT00055302
1033IL/0046
D5394C00046
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AstraZeneca
AstraZeneca
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Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
AstraZeneca
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP