A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy +
placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients
with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in
each group) patients are to be enrolled randomly into Tolvaptan group or placebo group.
Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while
those in control group receiving standard therapy + placebo. The starting dose of tolvaptan
is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg
according to a certain titration scheme based on patients' response of serum sodium level.
The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study
treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety
events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from
baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of
body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed
as secondary efficacy variables.