Non-hypovolemic Non-acute HyponatremiaPhase 2/3NCT01507727
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
A Phase 2/3 study testing Tolvaptan in people with Non-hypovolemic Non-acute Hyponatremia, run by Jiangsu HengRui Medicine Co., Ltd. at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-hypovolemic Non-acute Hyponatremia
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Informed consent.
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Fusheng Wang, PhD contact
China3 sites, 3 recruiting
- Recruiting
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science
Beijing
Suo, 010-64456464
Changsheng Ma, PhD
- Recruiting
Endocrinology, Beijing Friendship Hospital
Beijing
Liu, 010-84205645
Wenying Yang, PhD
- Recruiting
Hepatology, No. 302 Hospital
Beijing
Yu, 010-63879892
Fusheng Wang, PhD
About this study
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
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.
- Conditions
- Non-hypovolemic Non-acute Hyponatremia
- Being tested
- Tolvaptan, Placebo
- Keywords
- hyponatremia, Non-hypovolemic and Non-acute hyponatremia, Tolvaptan
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
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.
PlaceboDrug
placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Tolvaptan | Experimental | Not described Receives: Drug: Tolvaptan |
| Drug: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 and 7 days
Secondary outcomes (12)
Percentage of patients with normalized serum sodium at Day 4
Measured: 4 day
Percentage of patients with normalized serum sodium at Day 7
Measured: 7 day
Time to first normalization in serum sodium
Measured: up to 7 days
Change from baseline in serum sodium at Day 4
Measured: 4 day
Change from baseline in serum sodium at Day 7
Measured: 7 day
Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study
Measured: up to 7 days
24-hour urine output
Measured: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Change from baseline in body weight (hypervolemic patients only)
Measured: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Fluid balance (hypervolemic patients only)
Measured: 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
Measured: up to 7 days
For CHF patients, improvement of symptoms and relevant physical examination measures
Measured: 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
Measured: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hypovolemic Non-acute HyponatremiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital, Beijing Anzhen Hospital, Beijing Friendship Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507727
- Sponsor's protocol ID
- HENGRUI20111231
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01507727
- Acronym / sponsor ID
- HENGRUI20111231
- Conditions
- Non-hypovolemic Non-acute Hyponatremia
- Keywords
- hyponatremia, Non-hypovolemic and Non-acute hyponatremia, Tolvaptan
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital, Beijing Anzhen Hospital, Beijing Friendship Hospital
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Tolvaptan | Experimental | Drug: Tolvaptan |
| Drug: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolvaptanTablet;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 | Drug: Tolvaptan |
| Placeboplacebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others. | Drug | Drug: Placebo |
Primary outcome
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
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fusheng Wang, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tolvaptan in people with Non-hypovolemic Non-acute Hyponatremia, run by Jiangsu HengRui Medicine Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fusheng Wang, PhD (fswang@public.bta.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.