Status:
UNKNOWN
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Beijing 302 Hospital
Beijing Anzhen Hospital
Conditions:
Non-hypovolemic Non-acute Hyponatremia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01507727
Start Date
January 1 2012
End Date
September 1 2012
Last Update
January 11 2012
Active Locations (3)
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1
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science
Beijing, China
2
Endocrinology, Beijing Friendship Hospital
Beijing, China
3
Hepatology, No. 302 Hospital
Beijing, China