UnknownPhase 2/3

Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

China240 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Patients with hepatic edema.

What they're measuring

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

Trial details

NCT IDNCT01507727

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

Contact for this trial

Fusheng Wang, PhD

fswang@public.bta.net.cn

View on ClinicalTrials.gov More Non-hypovolemic Non-acute Hyponatremia trials