@ Steering Committee: TC to validate the final version of the protocol 14/10 at 12.00 CET
Please review the final version of PTC and especially the following topics:
Study design in synopsis:
Screening at week -2 ? cfr 6.3: "max 1 month before baseline"
SBP 160 AND/OR DBP>100
BMI>40= exclusion (up to 40=OK)
Visit 1 month, Visit 3 months, Visit 6 months, and Visit 9 months: liver tests by local lab if suspicion of liver disease/toxicity only
Lab parameters at B, 3,6,9,12: choose between 3 or 9 m
4.1: HR: should be <100 bpm at screening/baseline, then as per guidelines during the study (but not cause to exclude patient during the study)
6.3: Proposition to perform Central lab tests at 3 months instead of 9 months ? or keep at 9 months?
6.4: Termination in case of non-compliance: less than 50% doses taken
8.2: Liver function tests: mandatory at screening (local lab), then only to be repeated by local lab if suspicion of liver disease/toxicity (liver tests are included in Central lab measurements with biomarkers)
8.2: SAE: SBP>180 AND/OR DBP >110 mmHg
9.2.1: there is a proposition to use a different test for the statistical analysis of the 2 equally ranked primary endpoints
9.2.2: HOMA: cfr final decision on this
Thank you in advance for your availability,