Clinical Trial: Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Phase 3 Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Patients With Cardiac Edema

Brief Summary:

A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid retention caused by congestive heart failure) based on the conventional therapy.

To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients with body fluid retention after current diuretic treatment, after continuous treatment of 7 days' oral Tolvaptan 15mg or placebo.


Detailed Summary:

  • A randomized, double-blind, multicenter, placebo-controlled, parallel study
  • Study population: The congestive heart failure patients with body fluid retention after received current diuretics therapy
  • Number of patients: Patients will be randomly assigned to Tolvaptan and placebo group in 1:1 ratio, 120 patients in each group, 240 patients in total
  • Group assignment method: Tolvaptan 15 mg group: conventional therapy + Tolvaptan 15 mg Placebo group: conventional therapy + placebo
  • Administration and dosage of the study drug: Once daily, 1 tablet be taken orally after breakfast, for successive 7 days
  • Study period:
  • Screening period (4 days in minimum, 7 days in maximum), including:

Screening period: from the time the informed consent form is signed to Day -4 Observation period: 3 days before drug administration

  • Treatment period: 7 days
  • Follow up visits: Day 8 (efficacy evaluation day) and Day 7 (+3) after the last dosing
  • Post treatment survey: Day 14 (+3) after the last dosing

Sponsor: Otsuka Beijing Research Institute

Current Primary Outcome: body weight (change from baseline) [ Time Frame: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Body weight (percent change from baseline) [ Time Frame: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3) ]

Original Secondary Outcome: Same as current

Information By: Otsuka Beijing Research Institute

Dates:
Date Received: July 24, 2012
Date Started: July 2012
Date Completion:
Last Updated: December 25, 2013
Last Verified: December 2013