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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Cardiac Edema
- Sponsor
- Otsuka Beijing Research Institute
- Enrollment
- 244
- Locations
- 1
- Primary Endpoint
- body weight (change from baseline)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients treated with one of the oral diuretic therapy standards （include the patients who will be treated with one of the oral diuretic therapy standards from the beginning of the observation period）:
- •Only 40 mg/day furosemide taken orally or other oral loop diuretics equivalent to 40 mg/day furosemide note 1)
- •Combination treatment of oral loop diuretics and thiazide diuretics (no dosage limitation)
- •Combination treatment of oral loop diuretics and aldosterone antagonists (no dosage limitation)
- •Because of the existence of excess body fluid retention, the congestive heart failure patient has at least one of these symptoms (the lower extremity edema, pulmonary congestion note 2), or jugular vein engorgement).
- •20-85 years of age (inclusive) at the time of signing the informed consent document.
- •Gender: male or female.
- •Inpatients or patient who would be hospitalized from one day before the observation period to the end of efficacy evaluation examination after the last dosing (from Day -4 to the end of efficacy evaluation examination after the last dosing).
- •Patient who have signed the informed consent form.
Exclusion Criteria
- •Patients equipped with circulatory assistant device.
- •Patients with any of following diseases, complications or symptoms:
- •Suspected decreased blood volume
- •Obstructive hypertrophic cardiomyopathy
- •Severe aortic stenosis
- •Hepatic coma
- •Patients with history of acute myocardial infarction within 30 days prior to screening.
- •Patients with diagnosed active myocarditis or amyloid cardiomyopathy.
- •Patients with the following diseases, complications or symptoms:
- •Poorly controlled diabetes with a fasting glucose more than 220 mg/dL (or 12.21 mmol/L)
Arms & Interventions
placebo
Frequency: once per day Duration: 7days
Intervention: Placebo
Tolvaptan
Tolvaptan tablet Frequency: once per day Duration: 7days
Intervention: Tolvaptan
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Body weight (percent change from baseline)(screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3))