Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Public ClinicalTrials.gov record NCT02160145. 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
A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Study identification
- NCT ID
- NCT02160145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 1,370 participants
Conditions and interventions
Interventions
- Tolvaptan (OPC-41061) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- 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
- Apr 30, 2014
- Primary completion
- Apr 17, 2017
- Completion
- Apr 17, 2017
- Last update posted
- Aug 7, 2018
2014 – 2017
United States locations
- U.S. sites
- 82
- U.S. states
- 32
- U.S. cities
- 76
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35294 | — |
| Not listed | Huntsville | Alabama | 35805 | — |
| Not listed | Mobile | Alabama | 36617 | — |
| Not listed | Phoenix | Arizona | 85381 | — |
| Not listed | Tempe | Arizona | 85284 | — |
| Not listed | Tucson | Arizona | 85745 | — |
| Not listed | La Jolla | California | 92037 | — |
| Not listed | Los Angeles | California | 90022 | — |
| Not listed | Los Angeles | California | 90025 | — |
| Not listed | San Francisco | California | 94143 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Denver | Colorado | 80210 | — |
| Not listed | New Haven | Connecticut | 06520 | — |
| Not listed | Hudson | Florida | 34667 | — |
| Not listed | Jacksonville | Florida | 32216 | — |
| Not listed | Miami | Florida | 33150 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Port Charlotte | Florida | 33952 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Augusta | Georgia | 30909 | — |
| Not listed | Meridian | Idaho | 83642 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Kansas City | Kansas | 66160 | — |
| Not listed | Wichita | Kansas | 67214 | — |
| Not listed | Baton Rouge | Louisiana | 70808 | — |
| Not listed | Lafayette | Louisiana | 70503 | — |
| Not listed | Baltimore | Maryland | 21201 | — |
| Not listed | Greenbelt | Maryland | 20770 | — |
| Not listed | Rockville | Maryland | 20850 | — |
| Not listed | Wheaton | Maryland | 20906 | — |
| Not listed | Boston | Massachusetts | 02215 | — |
| Not listed | Springfield | Massachusetts | 01107 | — |
| Not listed | Detroit | Michigan | 48202 | — |
| Not listed | Kalamazoo | Michigan | 49007 | — |
| Not listed | Pontiac | Michigan | 48341 | — |
| Not listed | Roseville | Michigan | 48066 | — |
| Not listed | Minneapolis | Minnesota | 55404 | — |
| Not listed | Rochester | Minnesota | 55905 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Las Vegas | Nevada | 89128 | — |
| Not listed | Reno | Nevada | 89511 | — |
| Not listed | Eatontown | New Jersey | 07724 | — |
| Not listed | Voorhees Township | New Jersey | 08043 | — |
| Not listed | Buffalo | New York | 14215 | — |
| Not listed | Mineola | New York | 11501 | — |
| Not listed | New York | New York | 10016 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Rosedale | New York | 11422 | — |
| Not listed | Asheville | North Carolina | 28801 | — |
| Not listed | Chapel Hill | North Carolina | 27599-7155 | — |
| Not listed | Charlotte | North Carolina | 28207 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Fargo | North Dakota | 58122 | — |
| Not listed | Grand Forks | North Dakota | 58201 | — |
| Not listed | Akron | Ohio | 44302 | — |
| Not listed | Cincinnati | Ohio | 45206 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Columbus | Ohio | 43210 | — |
| Not listed | Portland | Oregon | 98686 | — |
| Not listed | Bethlehem | Pennsylvania | 18017 | — |
| Not listed | Doylestown | Pennsylvania | 18901 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Columbia | South Carolina | 29203 | — |
| Not listed | Orangeburg | South Carolina | 29118 | — |
| Not listed | Knoxville | Tennessee | 39723 | — |
| Not listed | Nashville | Tennessee | 37205 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Arlington | Texas | 76015 | — |
| Not listed | Houston | Texas | 77030-3411 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | McAllen | Texas | 78503 | — |
| Not listed | Burlington | Vermont | 05401 | — |
| Not listed | Arlington | Virginia | 22205 | — |
| Not listed | Charlottesville | Virginia | 22908 | — |
| Not listed | Norfolk | Virginia | 23507 | — |
| Not listed | Wenatchee | Washington | 98801 | — |
| Not listed | Morgantown | West Virginia | 26506 | — |
| Not listed | La Crosse | Wisconsin | 54601 | — |
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 148 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02160145, 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 Aug 7, 2018 · 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 NCT02160145 live on ClinicalTrials.gov.