A Phase 2/3 interventional study of Tolvaptan and Placebo in Non-hypovolemic Non-acute Hyponatremia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-01-11.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2/3, Interventional, and Treatment
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.
155 studies on the registry are indexed under Hyponatremia; 17 are open to participants now.
This study's planned enrollment of 240 is above the median of 58 across 92 interventional studies indexed under Hyponatremia.
Browse Hyponatremia studies →Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (for CHF):
Inclusion Criteria (for hepatic cirrhosis):
Inclusion Criteria (for SIADH and others):
Drug: Tolvaptan
Drug: Placebo
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.
placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
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
Time frame: 4 and 7 days
Percentage of patients with normalized serum sodium at Day 4
Time frame: 4 day
Percentage of patients with normalized serum sodium at Day 7
Time frame: 7 day
Time to first normalization in serum sodium
Time frame: up to 7 days
Change from baseline in serum sodium at Day 4
Time frame: 4 day
Change from baseline in serum sodium at Day 7
Time frame: 7 day
Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study
Time frame: up to 7 days
24-hour urine output
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Change from baseline in body weight (hypervolemic patients only)
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Fluid balance (hypervolemic patients only)
Time frame: 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
Time frame: up to 7 days
For CHF patients, improvement of symptoms and relevant physical examination measures
Time frame: 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
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangsu HengRui Medicine Co., Ltd.