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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Tolvaptan
    • 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.
  • Drug: Placebo
    • placebo plus conventional therapy according to each patient’s underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.

Arms, Groups and Cohorts

  • Experimental: Drug: Tolvaptan
  • Placebo Comparator: Drug: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Collaborator
    • Beijing 302 Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Fusheng Wang, PhD, fswang@public.bta.net.cn

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