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Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

Primary Purpose

Non-hypovolemic Non-acute Hyponatremia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tolvaptan
Placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-hypovolemic Non-acute Hyponatremia focused on measuring hyponatremia, Non-hypovolemic and Non-acute hyponatremia, Tolvaptan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (for CHF):

  1. Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, or pulmonary congestion.
  2. Non-hypovolemic and Non-acute hyponatremia with a serum sodium < 135mEq/L before randomization.
  3. Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period.
  4. Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration.
  5. Age:18～80 (when informed consent is obtained)，male or female.
  6. In-patient subjects.
  7. Informed consent.

Inclusion Criteria (for hepatic cirrhosis):

  1. Patients with hepatic edema.
  2. Non-hypovolemic and non acute hyponatremia with a serum sodium < 135mEq/L before randomization.
  3. Age:18～65 (when informed consent is obtained)，male or female.
  4. In-patient subjects.
  5. Informed consent.

Inclusion Criteria (for SIADH and others):

  1. Patients with SIADH arising from a variety of etiologies.
  2. Non-hypovolemic and non acute hyponatremia with a serum sodium < 135mEq/L before randomization.
  3. Age:18～80 (when informed consent is obtained)，male or female.
  4. In-patient subjects.
  5. Informed consent.

Sites / Locations

  • Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical ScienceRecruiting
  • Endocrinology, Beijing Friendship HospitalRecruiting
  • Hepatology, No. 302 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: Tolvaptan

Drug: Placebo

Arm Description

Outcomes

Primary Outcome Measures

The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period

Secondary Outcome Measures

Percentage of patients with normalized serum sodium at Day 4
Percentage of patients with normalized serum sodium at Day 7
Time to first normalization in serum sodium
Change from baseline in serum sodium at Day 4
Change from baseline in serum sodium at Day 7
Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study
24-hour urine output
Change from baseline in body weight (hypervolemic patients only)
Fluid balance (hypervolemic patients only)
The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction
For CHF patients, improvement of symptoms and relevant physical examination measures
For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings

Full Information

First Posted
January 5, 2012
Last Updated
January 8, 2012
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Beijing 302 Hospital, Beijing Anzhen Hospital, Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01507727
Brief Title
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled (Standard Therapy + Placebo) Study to Evaluate the Efficacy and Safety of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Beijing 302 Hospital, Beijing Anzhen Hospital, Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-hypovolemic Non-acute Hyponatremia
Keywords
hyponatremia, Non-hypovolemic and Non-acute hyponatremia, Tolvaptan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug: Tolvaptan
Arm Type
Experimental
Arm Title
Drug: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Intervention Description
Tablet;15mg/tab; 30mg/tab; 15/30/60mg/day for 7 days Plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
Primary Outcome Measure Information:
Title
The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period
Time Frame
4 and 7 days
Secondary Outcome Measure Information:
Title
Percentage of patients with normalized serum sodium at Day 4
Time Frame
4 day
Title
Percentage of patients with normalized serum sodium at Day 7
Time Frame
7 day
Title
Time to first normalization in serum sodium
Time Frame
up to 7 days
Title
Change from baseline in serum sodium at Day 4
Time Frame
4 day
Title
Change from baseline in serum sodium at Day 7
Time Frame
7 day
Title
Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study
Time Frame
up to 7 days
Title
24-hour urine output
Time Frame
day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Title
Change from baseline in body weight (hypervolemic patients only)
Time Frame
day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Title
Fluid balance (hypervolemic patients only)
Time Frame
day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Title
The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction
Time Frame
up to 7 days
Title
For CHF patients, improvement of symptoms and relevant physical examination measures
Time Frame
day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Title
For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings
Time Frame
day 1, day 2, day 3, day 4, day 5, day 6 and day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (for CHF): Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, or pulmonary congestion. Non-hypovolemic and Non-acute hyponatremia with a serum sodium < 135mEq/L before randomization. Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period. Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration. Age:18～80 (when informed consent is obtained)，male or female. In-patient subjects. Informed consent. Inclusion Criteria (for hepatic cirrhosis): Patients with hepatic edema. Non-hypovolemic and non acute hyponatremia with a serum sodium < 135mEq/L before randomization. Age:18～65 (when informed consent is obtained)，male or female. In-patient subjects. Informed consent. Inclusion Criteria (for SIADH and others): Patients with SIADH arising from a variety of etiologies. Non-hypovolemic and non acute hyponatremia with a serum sodium < 135mEq/L before randomization. Age:18～80 (when informed consent is obtained)，male or female. In-patient subjects. Informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fusheng Wang, PhD
Email
fswang@public.bta.net.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zhu
Phone
051885475957
Email
acetone_zhulin@yahoo.com.cn
Facility Information:
Facility Name
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suo
Phone
010-64456464
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, PhD
Facility Name
Endocrinology, Beijing Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu
Phone
010-84205645
First Name & Middle Initial & Last Name & Degree
Wenying Yang, PhD
Facility Name
Hepatology, No. 302 Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu
Phone
010-63879892
First Name & Middle Initial & Last Name & Degree
Fusheng Wang, PhD

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

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