Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
Public ClinicalTrials.gov record NCT01227512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA(r) (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized With Dilutional Hyponatremia
Study identification
- NCT ID
- NCT01227512
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 124 participants
Conditions and interventions
Interventions
- tolvaptan Drug
- Fluid Restriction Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Apr 30, 2013
- Completion
- Apr 30, 2013
- Last update posted
- Oct 29, 2014
2010 – 2013
United States locations
- U.S. sites
- 56
- U.S. states
- 23
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Otsuka Investigational Site | Birmingham | Alabama | 35216 | — |
| Otsuka Investigational Site | Birmingham | Alabama | 35242 | — |
| Otsuka Investigational Site | Mobile | Alabama | 36608 | — |
| Otsuka Investigational Site | Azusa | California | 91702 | — |
| Otsuka Investigational Site | Banning | California | 92220 | — |
| Otsuka Investigational Site | Culver City | California | 90232 | — |
| Otsuka Investigational Site | Fountain Valley | California | 92708 | — |
| Otsuka Investigational Site | Los Angeles | California | 90025 | — |
| Otsuka Investigational Site | Los Angeles | California | 90033 | — |
| Otsuka Investigational Site | Northridge | California | 91324 | — |
| Otuska Investigational Site | Orange | California | 92868 | — |
| Otsuka Investigational Site | Yorba Linda | California | 92886 | — |
| Otsuka Investigational Site | Denver | Colorado | 80210 | — |
| Otsuka Investigational Site | Washington D.C. | District of Columbia | 20010 | — |
| Otsuka Investigational Site | Jacksonville | Florida | 32207 | — |
| Otsuka Investigational Site | Jacksonville | Florida | 32209 | — |
| Otsuka Investigational Site | Jacksonville | Florida | 32216 | — |
| Otsuka Investigational Site | Orlando | Florida | 32803 | — |
| Otsuka Investigational Site | Port Charlotte | Florida | 33952 | — |
| Otsuka Investigational Site | Savannah | Georgia | 31405 | — |
| Otsuka Investigational Site | Elizabethtown | Kentucky | 42701 | — |
| Otsuka Investigational Site | Baltimore | Maryland | 21215 | — |
| Otsuka Investigational Site | Springfield | Massachusetts | 01107 | — |
| Otsuka Investigational Site | Saginaw | Michigan | 48602 | — |
| Otsuka Investigational Site | Southfield | Michigan | 48075 | — |
| Otsuka Investigational Site | Minneapolis | Minnesota | 55455 | — |
| Otsuka Investigational Site | Rochester | Minnesota | 55905 | — |
| Otsuka Investigational Site | Jackson | Mississippi | 39216 | — |
| Otsuka Investigational Site | St Louis | Missouri | 63110 | — |
| Otsuka Investigational Site | Grand Island | Nebraska | 68803 | — |
| Otsuka Investigational Site | Omaha | Nebraska | 68131 | — |
| Otsuka Investigational Site | Haddon Heights | New Jersey | 08035 | — |
| Otsuka Investigational Site | Newark | New Jersey | 07103 | — |
| Otsuka Investigational Site | Buffalo | New York | 14203 | — |
| Otsuka Investigational Site | Buffalo | New York | 14215 | — |
| Otsuka Investigational Site | Jamaica | New York | 11418 | — |
| Otsuka Investigational Site | New York | New York | 10032 | — |
| Otsuka Investigational Site | The Bronx | New York | 10461 | — |
| Otsuka Investigational Site | Cincinnati | Ohio | 45267 | — |
| Otsuka Investigational Site | Cleveland | Ohio | 44195 | — |
| Otsuka Investigational Site | Columbus | Ohio | 43212 | — |
| Otsuka Investigational Site | Fairfield | Ohio | 45014 | — |
| Otsuka Investigational Site | Toledo | Ohio | 43560 | — |
| Otsuka Investigational Site | Oklahoma City | Oklahoma | 73120 | — |
| Otsuka Investigational Site | Bethleham | Pennsylvania | 18017 | — |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19102 | — |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19140 | — |
| Otsuka Investigational Site | West Reading | Pennsylvania | 19611 | — |
| Otsuka Investigational Site | Providence | Rhode Island | 02903 | — |
| Otsuka Investigational Site | Galveston | Texas | 77555 | — |
| Otsuka Investigational Site | Houston | Texas | 77030 | — |
| Otsuka Investigational Site | Mission | Texas | 78572 | — |
| Otsuka Investigational Site | San Antonio | Texas | 78205 | — |
| Otsuka Investigational Site | San Antonio | Texas | 78229 | — |
| Otsuka Investigational Site | Fairfax | Virginia | 22030 | — |
| Otsuka Investigational Site | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01227512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2014 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01227512 live on ClinicalTrials.gov.