Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
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ClinicalTrials.gov Identifier: NCT01507727 |
Recruitment Status
: Unknown
Verified January 2012 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Recruiting
First Posted
: January 11, 2012
Last Update Posted
: January 11, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-hypovolemic Non-acute Hyponatremia | Drug: Tolvaptan Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
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.
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- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507727
Contact: Fusheng Wang, PhD | fswang@public.bta.net.cn | ||
Contact: Lin Zhu | 051885475957 | acetone_zhulin@yahoo.com.cn |
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 |
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01507727 History of Changes |
Other Study ID Numbers: |
HENGRUI20111231 |
First Posted: | January 11, 2012 Key Record Dates |
Last Update Posted: | January 11, 2012 |
Last Verified: | January 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 |