Trials / Completed
CompletedNCT00658879
Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
SPECIAL INVESTIGATION OF SOMAVERT -LONG TERM USE-
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 251 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 0 Days
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
All the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Somavert (Pegvisomant) | Somavert (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. |
Timeline
- Start date
- 2007-08-07
- Primary completion
- 2016-11-09
- Completion
- 2016-11-09
- First posted
- 2008-04-15
- Last updated
- 2023-09-25
- Results posted
- 2019-01-22
Source: ClinicalTrials.gov record NCT00658879. Inclusion in this directory is not an endorsement.