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

Cardiac Edema Clinical Trial

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 Based on the Conventional Therapy

Status Completed

Clinical Trial 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.

Clinical Trial Description

• 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Edema
• Edema
• Edema, Cardiac

• NCT number: NCT01651156
• Study type: Interventional
• Source: Otsuka Beijing Research Institute
• Status: Completed
• Phase: Phase 3
• Start date: July 2012
• Completion date: July 2013