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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2012 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Recruiting

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome 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 ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (for CHF):

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.

Inclusion Criteria (for hepatic cirrhosis):

Patients with hepatic edema.
Non-hypovolemic and non acute hyponatremia with a serum sodium < 135mEq/L before randomization.
Age:18～65 (when informed consent is obtained)，male or female.
In-patient subjects.
Informed consent.

Inclusion Criteria (for SIADH and others):

Patients with SIADH arising from a variety of etiologies.
Non-hypovolemic and non acute hyponatremia with a serum sodium < 135mEq/L before randomization.
Age:18～80 (when informed consent is obtained)，male or female.
In-patient subjects.
Informed consent.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Hepatology, No. 302 Hospital	Recruiting
Beijing, China
Contact: Yu 010-63879892
Principal Investigator: Fusheng Wang, PhD

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Beijing 302 Hospital

Beijing Anzhen Hospital

Beijing Friendship Hospital

More Information


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

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 Tolvaptan	Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017

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