Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Public ClinicalTrials.gov record NCT00428948. 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 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Study identification
- NCT ID
- NCT00428948
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,445 participants
Conditions and interventions
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
- Jan 2007 (Type not available)
- Primary completion
- Jan 2012 (Actual)
- Completion
- Jan 2012 (Actual)
- Last update posted
- Jul 2, 2017
2007 – 2012
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research | Mobile | Alabama | 36608 | — |
| University of South Alabama | Mobile | Alabama | 36617 | — |
| Apex Research of Riverside | Riverside | California | 92503 | — |
| Stanford University Medical Center | Stanford | California | 94305-5114 | — |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Coastal Nephrology Associates Research Center, LLC | Port Charlotte | Florida | 33952 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30308 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Renal Associates of Baton Rough, L.L.C. | Baton Rouge | Louisiana | 70809 | — |
| John Hopkins School of Medicine | Baltimore | Maryland | 21205 | — |
| Tufts- New England Medical Center | Boston | Massachusetts | 02111 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Mayo Medical Center | Rochester | Minnesota | 55905 | — |
| Erie County Medical Center | Buffalo | New York | 14215 | — |
| Nephrology Associates of Westchester | Hawthorne | New York | 10532 | — |
| The Rogosin Institute | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of North Carolina, UNC, Kidney Center | Chapel Hill | North Carolina | 27599 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Kidney and Hypertension Center | Cincinnati | Ohio | 45220 | — |
| University Hospitals of Cleveland/Case | Cleveland | Ohio | 44106 | — |
| Northwest Renal Clinic, Inc. | Portland | Oregon | 97210 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Charleston Nephrology Associates | Charleston | South Carolina | 29405 | — |
| Nephrology Associates, P.C. | Nashville | Tennessee | 37205 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-1371 | — |
| University of Virginia, Nephrology Clinical Research Center | 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 103 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00428948, 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 Jul 2, 2017 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00428948 live on ClinicalTrials.gov.