A Multicenter, Randomized, Double-blind, Placebo-controlled (Standard Therapy + Placebo) Study to Evaluate the Efficacy and Safety of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

Jiangsu HengRui Medicine Co., Ltd.3 sites in 1 country240 target enrollmentJanuary 2012

ConditionsNon-hypovolemic Non-acute Hyponatremia

InterventionsTolvaptan Placebo

DrugsTolvaptan Placebo

Overview

Phase: Phase 2
Intervention: Tolvaptan
Conditions: Non-hypovolemic Non-acute Hyponatremia
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 240
Locations: 3
Primary Endpoint: The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

September 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Drug: Tolvaptan

Intervention: Tolvaptan

Drug: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period

Time Frame: 4 and 7 days

Secondary Outcomes

Percentage of patients with normalized serum sodium at Day 4(4 day)
Percentage of patients with normalized serum sodium at Day 7(7 day)
Time to first normalization in serum sodium(up to 7 days)
Change from baseline in serum sodium at Day 4(4 day)
Change from baseline in serum sodium at Day 7(7 day)
Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study(up to 7 days)
24-hour urine output(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
Change from baseline in body weight (hypervolemic patients only)(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
Fluid balance (hypervolemic patients only)(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction(up to 7 days)
For CHF patients, improvement of symptoms and relevant physical examination measures(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)