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.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
244
Zhejiang Hospital
Hangzhou, Zhejiang, China
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)
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)
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