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Table 2 Endpoint measures and timings for the 1366.0029 trial

From: The rationale and study design of two phase II trials examining the effects of BI 685509, a soluble guanylyl cyclase activator, on clinically significant portal hypertension in patients with compensated cirrhosis

  1. †Screening visits should be completed within 4 weeks; a maximum of 6 weeks (42 days) will be permitted
  2. ‡PK sampling of BI 685509 and empagliflozin
  3. BP blood pressure, CAP controlled attenuation parameter, ECG electrocardiogram, EoS end of study, EoT end of treatment, HR heart rate, HVPG hepatic venous pressure gradient, IRT Interactive Response Technology, LSM liver stiffness measure, PG pressure gradient, PK pharmacokinetic, PRO patient-reported outcome
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Trials

ISSN: 1745-6215