Non-hypovolemic Non-acute Hyponatremia Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science | Beijing | |
| China | Endocrinology, Beijing Friendship Hospital | Beijing | |
| China | Hepatology, No. 302 Hospital | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | Beijing 302 Hospital, Beijing Anzhen Hospital, Beijing Friendship Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 4 and 7 days | Yes | |
| Secondary | Percentage of patients with normalized serum sodium at Day 4 | 4 day | Yes | |
| Secondary | Percentage of patients with normalized serum sodium at Day 7 | 7 day | Yes | |
| Secondary | Time to first normalization in serum sodium | up to 7 days | Yes | |
| Secondary | Change from baseline in serum sodium at Day 4 | 4 day | Yes | |
| Secondary | Change from baseline in serum sodium at Day 7 | 7 day | Yes | |
| Secondary | Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study | up to 7 days | Yes | |
| Secondary | 24-hour urine output | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | Yes | |
| Secondary | Change from baseline in body weight (hypervolemic patients only) | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | Yes | |
| Secondary | Fluid balance (hypervolemic patients only) | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | Yes | |
| Secondary | The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction | up to 7 days | Yes | |
| Secondary | For CHF patients, improvement of symptoms and relevant physical examination measures | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | Yes | |
| Secondary | For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | Yes |