A medical follow-up study in patients who received BGG492 for more than 28 days.
- Conditions
- Testing for adrenal cortical adenomas in male and female patientsTesting for uterine endometrial stromal sarcromas in all female patientsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003431-29-IT
- Lead Sponsor
- ovartis Farma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 77
1.Written informed consent must be obtained before any assessment is performed;
2.Patients must be cooperative, willing to participate in the study assessments, and able to report adverse events themselves or have a caregiver who can record and report the events;
3.Total exposure to BGG492 treatment in study CBGG492A2207 and/or CBGG492A2212 must have been greater than 28 days;
4.At least one year must have elapsed since the patient received his or her last dose of BGG492.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17
There are no exclusion criteria for this study so that all patients meeting the inclusion criteria will be eligible to participate in the medical follow-up assessments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method