Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01651156
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2012-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema
Sponsor:
Otsuka Beijing Research Institute
Organization:
Study Overview
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
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: