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

Primary Purpose

Cardiac Edema

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tolvaptan
Placebo
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Edema

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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）:

    1. Only 40 mg/day furosemide taken orally or other oral loop diuretics equivalent to 40 mg/day furosemide note 1)
    2. Combination treatment of oral loop diuretics and thiazide diuretics (no dosage limitation)
    3. 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:

    1. Suspected decreased blood volume
    2. Obstructive hypertrophic cardiomyopathy
    3. Severe aortic stenosis
    4. 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:

    1. Poorly controlled diabetes with a fasting glucose more than 220 mg/dL (or 12.21 mmol/L)
    2. Anuria
    3. Dysuria caused by urethral stricture, calculus or tumor

  • Patients with the following medical history of:

    1. Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to screening
    2. History of cerebrovascular accident within the past 30 days
    3. Past allergy or hypersensitive reactions to benzodiazepines (e.g. mozavaptan hydrochloride or benazepril hydrochloride)
  • Obese patients whose body mass index (BMI = body weight (kg) / height (m)2 ) is more than 35.
  • Patients with systolic pressure below 90 mmHg in supine position.

  • Patients with any of the following abnormal laboratory test parameters:

    1. Total bilirubin > 2.5 times the upper limits of normal value
    2. Serum creatine > 2.5 times the upper limits of normal value
    3. Serum Na+ > 145 mmol/L (or higher than the upper limits of normal value)
    4. Serum K+ > 5.5 mmol/L
  • Patients who unable to take medicine orally.
  • Female patients who are pregnant, breast-feeding, at childbearing ages, or with pregnancy plan.
  • Patients who participated in clinical trials of other medicine and took other study drugs within 30 days prior to sign the informed consent form.
  • Patients who participated in the clinical trial of Tolvaptan and took Tolvaptan previously.
  • Patients who have received approved Tolvaptan tablets (Trade name: Samsca) previously.
  • Except for the above, patients who were unsuitable to participate in this trial in the investigator's opinion.

Sites / Locations

  • Zhejiang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

Tolvaptan

Arm Description

Frequency: once per day Duration: 7days

Tolvaptan tablet Frequency: once per day Duration: 7days

Outcomes

Primary Outcome Measures

body weight (change from baseline)

Secondary Outcome Measures

Body weight (percent change from baseline)

Full Information

First Posted
July 24, 2012
Last Updated
December 25, 2013
Sponsor
Otsuka Beijing Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01651156
Brief Title
Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Beijing Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Frequency: once per day Duration: 7days
Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
Tolvaptan tablet Frequency: once per day Duration: 7days
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
Samsca
Intervention Description
oral taken
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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) 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 Past allergy or hypersensitive reactions to benzodiazepines (e.g. mozavaptan hydrochloride or benazepril hydrochloride) Obese patients whose body mass index (BMI = body weight (kg) / height (m)2 ) is more than 35. Patients with systolic pressure below 90 mmHg in supine position. Patients with any of the following abnormal laboratory test parameters: Total bilirubin > 2.5 times the upper limits of normal value Serum creatine > 2.5 times the upper limits of normal value Serum Na+ > 145 mmol/L (or higher than the upper limits of normal value) Serum K+ > 5.5 mmol/L Patients who unable to take medicine orally. Female patients who are pregnant, breast-feeding, at childbearing ages, or with pregnancy plan. Patients who participated in clinical trials of other medicine and took other study drugs within 30 days prior to sign the informed consent form. Patients who participated in the clinical trial of Tolvaptan and took Tolvaptan previously. Patients who have received approved Tolvaptan tablets (Trade name: Samsca) previously. Except for the above, patients who were unsuitable to participate in this trial in the investigator's opinion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Jian
Organizational Affiliation
Fuwai Cardiovascular hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China

12. IPD Sharing Statement

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

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