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GLAXOSMITH New Study on Avodart - January 2010


#1

This looks new as it was submitted on October 29, 2009. Are they reconsidering?

Purpose
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of AVODAR® administered in Korean androgenetic alopecia patients according to the prescribing information

Condition Intervention
Alopecia
Drug: AVODAR®

Study Type: Observational
Study Design: Prospective
Official Title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and Effectiveness of AVODART® Administered in Korean Androgenetic Alopecia Patients According to the Prescribing Information

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia
MedlinePlus related topics: Hair Problems
Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
•Occurrence of adverse event after AVODAR® administration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
•Effectiveness after AVODAR® administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

•Occurrence of unexpected or serious adverse event after AVODAR® administration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment: 900
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AVODART®
Patients administrated AVODAR® at the site Drug: AVODAR®
Basically there is no treatment allocation. Subjects who would be administered of AVODAR® at their physicians’ discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Eligibility

Ages Eligible for Study: 18 Years to 41 Years
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population
Patients administrated AVODART® at the site

Criteria
Inclusion Criteria:

•Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia)
•Subjects with no experience of treatment using dutasteride
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
•Subjects who provide informed consent for providing their medical information.
Exclusion Criteria:

•Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with AVODART® following the locally approved Prescribing Information
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004809

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 113797
Study First Received: October 29, 2009
Last Updated: October 29, 2009
ClinicalTrials.gov Identifier: NCT01004809 History of Changes
Health Authority: South Korea: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dutasteride

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Hair Diseases
Hypotrichosis
Skin Diseases
Alopecia

ClinicalTrials.gov processed this record on December 16, 2009