Tolvaptan Extension Study in Participants With ADPKD
Public ClinicalTrials.gov record NCT01214421. 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
Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
Study identification
- NCT ID
- NCT01214421
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,083 participants
Conditions and interventions
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
- May 26, 2010 (Actual)
- Primary completion
- Feb 29, 2016 (Actual)
- Completion
- Feb 29, 2016 (Actual)
- Last update posted
- Oct 25, 2021
2010 – 2016
United States locations
- U.S. sites
- 38
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Otsuka Investigational Site | Mobile | Alabama | 36617 | — |
| Otsuka Investigational Site | Peoria | Arizona | 85381 | — |
| Otsuka Investigational Site | Tempe | Arizona | 85284 | — |
| Otsuka Investigational Site | Los Angeles | California | 90025 | — |
| Otsuka Investigational Site | Palo Alto | California | 94304 | — |
| Otsuka Investigational Site | San Diego | California | 92108 | — |
| Otsuka Investigational Site | Aurora | Colorado | 80045 | — |
| Otsuka Investigational Site | New Haven | Connecticut | 06510 | — |
| Otsuka Investigational Site | Jacksonville | Florida | 32216 | — |
| Otsuka Investigational Site | Port Charlotte | Florida | 33952 | — |
| Otsuka Investigational Site | Atlanta | Georgia | 30322 | — |
| Otsuka Investigational Site | Augusta | Georgia | 30909 | — |
| Otsuka Investigational Site | Chicago | Illinois | 60611 | — |
| Otsuka Investigational Site | Kansas City | Kansas | 66160 | — |
| Otsuka Investigational Site | Baton Rouge | Louisiana | 70808 | — |
| Otsuka Investigational Site | Baltimore | Maryland | 21205 | — |
| Otsuka Investigational Site | Rockville | Maryland | 20850 | — |
| Otsuka Investigational Site | Boston | Massachusetts | 02111 | — |
| Otsuka Investigational Site | Detroit | Michigan | 48236 | — |
| Otsuka Investigational Site | Minneapolis | Minnesota | 55404 | — |
| Otsuka Investigational Site | Rochester | Minnesota | 55905 | — |
| Otsuka Investigational Site | Voorhees Township | New Jersey | 08043 | — |
| Otsuka Investigational Site | Buffalo | New York | 14215 | — |
| Otsuka Investigational Site | Hawthorne | New York | 10532 | — |
| Otsuka Investigational Site | New York | New York | 10021 | — |
| Otsuka Investigational Site | New York | New York | 10032 | — |
| Otsuka Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Otsuka Investigational Site | Cincinnati | Ohio | 45246 | — |
| Otsuka Investigational Site | Cleveland | Ohio | 44106 | — |
| Otsuka Investigational Site | Portland | Oregon | 97210 | — |
| Otsuka Investigational Site | Bethlehem | Pennsylvania | 18017 | — |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| Otsuka Investigational Site | Anderson | South Carolina | 29621 | — |
| Otsuka Investigational Site | Nashville | Tennessee | 37205 | — |
| Otsuka Investigational Site | Nashville | Tennessee | 37232 | — |
| Otsuka Investigational Site | Arlington | Texas | 76015 | — |
| Otsuka Investigational Site | McAllen | Texas | 78503 | — |
| Otsuka Investigational Site | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01214421, 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 25, 2021 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT01214421 live on ClinicalTrials.gov.