Trial · NCT01507727
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
NCT01507727, Phase 2, Phase 3, Unknown, Jiangsu HengRui Medicine Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia. Trials, record NCT01507727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01507727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
- NCT number
- NCT01507727
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Conditions
- Non-hypovolemic Non-acute Hyponatremia
- Interventions
- Tolvaptan, Placebo
- First posted
- 2012-01-11
- Last updated
- 2012-01-11
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 4 and 7 days | |
| Secondary | Percentage of patients with normalized serum sodium at Day 4 | 4 day | |
| Secondary | Percentage of patients with normalized serum sodium at Day 7 | 7 day | |
| Secondary | Time to first normalization in serum sodium | up to 7 days | |
| Secondary | Change from baseline in serum sodium at Day 4 | 4 day | |
| Secondary | Change from baseline in serum sodium at Day 7 | 7 day | |
| Secondary | Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study | up to 7 days | |
| Secondary | 24-hour urine output | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | |
| Secondary | Change from baseline in body weight (hypervolemic patients only) | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 | |
| Secondary | Fluid balance (hypervolemic patients only) | day 1, day 2, day 3, day 4, day 5, day 6 and day 7 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01507727
GET https://conductscience.org/api/trials/v1/NCT01507727/registered