Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

Completed · Phase 2

Conditions studied: Adrenocortical Adenoma, Endometrial Stromal Sarcomas

In brief

To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Key facts

Study ID

NCT02150213

Run by

Novartis Pharmaceuticals

People needed

59

Starts

2014-08-01

Expected to finish

2015-09-01

Last updated by the study team

2016-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent had to be obtained before any assessment was performed;
• Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
• Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
• At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.

You may not qualify if…

• There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments

Where it is running

• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Hoffman, New Jersey, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Bernau, Germany
• Novartis Investigative Site — Bielefeld, Germany
• Novartis Investigative Site — Bonn, Germany
• Novartis Investigative Site — Kehl-Kork, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Kecskemét, Hungary
• Novartis Investigative Site — Szombathely, Hungary
• Novartis Investigative Site — Florence, FI, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Hlohovec, Slovak Republic, Slovakia
• Novartis Investigative Site — Košice, Slovak Republic, Slovakia
• Novartis Investigative Site — Banská Bystrica, Slovakia, Slovakia
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea

Full record on ClinicalTrials.gov

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