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

NCT01651156 | Completed Phase 3

• 1 other identifier: 156-12-809-01
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Edema

Outcome Measures

Primary Outcomes (1)

• body weight (change from baseline)

  screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3)

Secondary Outcomes (1)

• 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)

Study Arms (2)

placebo

PLACEBO COMPARATOR

Frequency: once per day Duration: 7days

Drug: Placebo

Tolvaptan

EXPERIMENTAL

Tolvaptan tablet Frequency: once per day Duration: 7days

Drug: Tolvaptan

Interventions

Tolvaptan DRUG

oral taken

Also known as: Samsca

Tolvaptan

Placebo DRUG

placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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)
• Anuria
• Dysuria caused by urethral stricture, calculus or tumor
• Patients with the following medical history of:
• Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to screening
• History of cerebrovascular accident within the past 30 days

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Location

MeSH Terms

Conditions

Edema, Cardiac

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Edema; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhang Jian

  Fuwai Cardiovascular hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

CN (1)