CompletedPhase 2

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

United States, Germany59 participantsStarted 2014-08

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Incidence of Adrenal Cortical Adenomas

Timeframe: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

Incidence of Uterine Endometrial Stromal Sarcomas

Timeframe: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

Trial details

NCT IDNCT02150213

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-09

Results submitted2016-06-14

View on ClinicalTrials.gov More Adrenocortical Adenoma trials