NCT01584557

Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management

A Phase 3 Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Cardiovascular Clinical Sciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Tolvaptan or Samsca	uncoated tablet, 30mg, once per day, for up to 7 days.
DRUG	placebo or sugar pill	sugar pill

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2012-04-25
• Last updated: 2016-09-27

Locations

37 sites across 1 country: United States