Clinical trial NCT01507727: Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non-hypovolemic Non-acute Hyponatremia
Keywords: hyponatremia
Non-hypovolemic and Non-acute hyponatremia
Tolvaptan
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing 302 Hospital
name: Beijing Anzhen Hospital
name: Beijing Friendship Hospital
First posted: 2012-01-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 4 and 7 days
Secondary outcomes:
measure: Percentage of patients with normalized serum sodium at Day 4
timeFrame: 4 day
measure: Percentage of patients with normalized serum sodium at Day 7
timeFrame: 7 day
measure: Time to first normalization in serum sodium
timeFrame: up to 7 days
measure: Change from baseline in serum sodium at Day 4
timeFrame: 4 day
measure: Change from baseline in serum sodium at Day 7
timeFrame: 7 day
measure: Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study
timeFrame: up to 7 days
measure: 24-hour urine output
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
measure: Change from baseline in body weight (hypervolemic patients only)
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
measure: Fluid balance (hypervolemic patients only)
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
measure: The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction
timeFrame: up to 7 days
measure: For CHF patients, improvement of symptoms and relevant physical examination measures
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
measure: For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science
city: Beijing
country: China
facility: Endocrinology, Beijing Friendship Hospital
city: Beijing
country: China
facility: Hepatology, No. 302 Hospital
Study officials:
References: