Non-hypovolemic Non-acute Hyponatremia
Conditions
Keywords
hyponatremia, Non-hypovolemic and Non-acute hyponatremia, Tolvaptan
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.
Interventions
DRUGTolvaptan
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.
DRUGPlacebo
placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
Sponsors
Beijing 302 Hospital
Beijing Anzhen Hospital
Beijing Friendship Hospital
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with normalized serum sodium at Day 7 | 7 day |
| Time to first normalization in serum sodium | up to 7 days |
| Change from baseline in serum sodium at Day 4 | 4 day |
| Change from baseline in serum sodium at Day 7 | 7 day |
| Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study | up to 7 days |
| Percentage of patients with normalized serum sodium at Day 4 | 4 day |
| Change from baseline in body weight (hypervolemic patients only) | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 |
| Fluid balance (hypervolemic patients only) | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 |
| 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 |
| 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 |
| 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 |
| 24-hour urine output | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 |
Countries
China
Contacts
Primary ContactFusheng Wang, PhD
Backup ContactLin Zhu
Outcome results
None listed