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

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Beijing 302 Hospital; Beijing Anzhen Hospital; Beijing Friendship Hospital
• Treatments: Tolvaptan

Criteria

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.