Table 3.

Safety criteria

1)Potassium ≤ 5.4 mmol/L

2)No reduction in estimated glomerular filtration rate of > 35% from Visit 1 screening;

3)No symptomatic hypotension with systolic blood pressure < 90 mm Hg;

4)Adverse events:

Postural symptoms: physical symptoms that occur or worsen when changing positions, such as standing up from a seated or lying position (ie, fainting, dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, and headache).

Adverse events include any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease that occurs during the study, whether or not it is considered to be related to the study drug.

Serious adverse events are defined by any adverse event fulfilling at least one of the following criteria: fatal, life-threatening, requiring in-patient hospitalization, or prolongation of existing hospitalization, resulting in persistent or significant disability or incapacity or medically significant, or requires intervention to prevent at least one of the outcomes listed above.