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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-hypovolemic Non-acute Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug: Tolvaptan

Group Type EXPERIMENTAL

Tolvaptan

Intervention Type DRUG

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.

Drug: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.

Interventions

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Tolvaptan

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

Placebo

placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No