Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Public ClinicalTrials.gov record NCT00413777. 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, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients 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 of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).
Study identification
- NCT ID
- NCT00413777
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 46 participants
Conditions and interventions
Conditions
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
- Dec 2005 (Type not available)
- Primary completion
- Jun 2010 (Actual)
- Completion
- Jun 2010 (Actual)
- Last update posted
- Jul 2, 2017
2005 – 2010
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado | Denver | Colorado | — | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | — | — |
| Emory University School of Medicine | Atlanta | Georgia | — | — |
| Univerisity of Kansas Medical Center | Kansas City | Kansas | — | — |
| Johns Hopkins School of Medicine | Baltimore | Maryland | — | — |
| Davita Clinical Research | Minneapolis | Minnesota | — | — |
| Mayo Medical Center | Rochester | Minnesota | — | — |
| Rogosin Institute | New York | New York | — | — |
| Northwest Renal Clinic | Portland | Oregon | — | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | — | — |
| Nephrology Clinical Research Center at the University of Virginia | Charlottesville | Virginia | — | — |
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 NCT00413777, 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 NCT00413777 live on ClinicalTrials.gov.