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Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00658879
First received: April 9, 2008
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition Intervention
Acromegaly
Drug: Pegvisomant

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Somavert -Long Term Use-

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) [ Time Frame: 5 years ]
  • Factors considered to affect the safety and/or efficacy of this drug [ Time Frame: 5 years ]
  • The incidence of adverse drug reactions in this surveillance [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes measures. [ Time Frame: There is no secondary outcomes for this surveillance. ]

Enrollment: 251
Actual Study Start Date: August 7, 2007
Study Completion Date: November 9, 2016
Primary Completion Date: November 9, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pegvisomant
Patients taking Pegvisomant.
Drug: Pegvisomant

Pegvisomant 10, 15 or 20mg powder and solvent for solution for injection.

Dosage, Frequency : According to Japanese LPD.

Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration.


Detailed Description:
All the patients whom an investigator prescribes the first Pegvisomant should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A6291023 prescribes the Pegvisomant.
Criteria

Inclusion Criteria:

Patients need to be administered Pegvisomant in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Pegvisomant.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658879

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658879     History of Changes
Other Study ID Numbers: A6291023
Study First Received: April 9, 2008
Last Updated: March 6, 2017

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017