8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Public ClinicalTrials.gov record NCT01451827. 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 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease
Study identification
- NCT ID
- NCT01451827
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 178 participants
Conditions and interventions
Conditions
Interventions
- Tolvaptan MR Drug
- Tolvaptan IR Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 50 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
- Sep 30, 2011
- Primary completion
- Jun 30, 2013
- Completion
- Jun 30, 2013
- Last update posted
- Sep 26, 2018
2011 – 2013
United States locations
- U.S. sites
- 35
- U.S. states
- 25
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Otsuka Investigational Site | Huntsville | Alabama | 35802 | — |
| 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 | San Diego | California | 92108 | — |
| Otsuka Investigational Site 2 | Aurora | Colorado | 80045 | — |
| Otsuka Investigational Site | Aurora | Colorado | 80045 | — |
| Otsuka Investigational Site | Denver | Colorado | 80210 | — |
| Otsuka Investigational Site | New Haven | Connecticut | 06510 | — |
| Otsuka Investigational Site | Jacksonville | Florida | 32216 | — |
| Otsuka Investigational Site | Melbourne | Florida | 32935 | — |
| Otsuka Investigational Site | Atlanta | Georgia | 30322 | — |
| Otsuka Investigational Site | Augusta | Georgia | 30901 | — |
| Otsuka Investigational Site | Peoria | Illinois | 61602 | — |
| Otsuka Investigational Site | Mishawaka | Indiana | 46545 | — |
| Otsuka Investigational Site | Kansas City | Kansas | 66160 | — |
| Otsuka Investigational Site | Paducah | Kentucky | 42003 | — |
| Otsuka Investigational Site | Shreveport | Louisiana | 71101 | — |
| Otsuka Investigational Site | Baltimore | Maryland | 21224 | — |
| Otsuka Investigational Site | Rockville | Maryland | 20850 | — |
| Otsuka Investigational Site | Boston | Massachusetts | 02111 | — |
| Otsuka Investigational Site | Detroit | Michigan | 48236 | — |
| Otsuka Investigational Site | Rochester | Minnesota | 55905 | — |
| Otsuka Investigational Site | Voorhees Township | New Jersey | 08043 | — |
| Otsuka Investigational Site | Buffalo | New York | 14215 | — |
| Otsuka Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Otsuka Investigational Site | Cleveland | Ohio | 44106 | — |
| 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 | Arlington | Texas | 76015 | — |
| Otsuka Investigational Site | Mission | Texas | 78572 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01451827, 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 Sep 26, 2018 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01451827 live on ClinicalTrials.gov.