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

This study is currently recruiting participants.
Verified January 2012 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Collaborators:
Beijing 302 Hospital
Beijing Anzhen Hospital
Beijing Friendship Hospital
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01507727
First received: January 5, 2012
Last updated: January 8, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-hypovolemic Non-acute Hyponatremia
 Drug: Tolvaptan
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Tolvaptan
U.S. FDA Resources

Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients with normalized serum sodium at Day 4 [ Time Frame: 4 day ] [ Designated as safety issue: Yes ]
  • Percentage of patients with normalized serum sodium at Day 7 [ Time Frame: 7 day ] [ Designated as safety issue: Yes ]
  • Time to first normalization in serum sodium [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum sodium at Day 4 [ Time Frame: 4 day ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum sodium at Day 7 [ Time Frame: 7 day ] [ Designated as safety issue: Yes ]
  • Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
  • 24-hour urine output [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Fluid balance (hypervolemic patients only) [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Tolvaptan 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.
Placebo Comparator: Drug: Placebo Drug: Placebo
placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507727

Contacts
Contact: Fusheng Wang, PhD fswang@public.bta.net.cn
Contact: Lin Zhu 051885475957 acetone_zhulin@yahoo.com.cn

Locations
China
Hepatology, No. 302 Hospital Recruiting
Beijing, China
Contact: Yu     010-63879892        
Principal Investigator: Fusheng Wang, PhD            
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science Recruiting
Beijing, China
Contact: Suo     010-64456464        
Principal Investigator: Changsheng Ma, PhD            
Endocrinology, Beijing Friendship Hospital Recruiting
Beijing, China
Contact: Liu     010-84205645        
Principal Investigator: Wenying Yang, PhD            
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Beijing 302 Hospital
Beijing Anzhen Hospital
Beijing Friendship Hospital
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01507727     History of Changes
Other Study ID Numbers: HENGRUI20111231
Study First Received: January 5, 2012
Last Updated: January 8, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
hyponatremia
Non-hypovolemic and Non-acute hyponatremia
Tolvaptan

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013