Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01651156
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 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:
NCT01651156
Study Brief:
Protocol Section:
NCT01651156