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Completed Phase 3 Interventional Results available

Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

ClinicalTrials.gov ID: NCT02251275

Public ClinicalTrials.gov record NCT02251275. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:26 PM EDT

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, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).

Study identification

NCT ID
NCT02251275
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,803 participants

Conditions and interventions

Interventions

Drug

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
Oct 17, 2014 (Actual)
Primary completion
Nov 9, 2018 (Actual)
Completion
Nov 9, 2018 (Actual)
Last update posted
Nov 27, 2019

2014 – 2018

United States locations

U.S. sites
81
U.S. states
31
U.S. cities
73
Facility City State ZIP Site status
Not listed Birmingham Alabama 35233 —
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 90095 —
Not listed San Francisco California 94143 —
Not listed Stanford California 94305 —
Not listed Aurora Colorado 80045 —
Not listed Denver Colorado 80204 —
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 60611 —
Not listed Chicago Illinois 60637 —
Not listed Kansas City Kansas 66160 —
Not listed Wichita Kansas 67214 —
Not listed Baton Rouge Louisiana 70808 —
Not listed Baltimore Maryland 21201 —
Not listed Baltimore Maryland 21224 —
Not listed Greenbelt Maryland 20770 —
Not listed Rockville Maryland 20850 —
Not listed Boston Massachusetts 02111 —
Not listed Springfield Massachusetts 01107 —
Not listed Detroit Michigan 48202 —
Not listed Grand Rapids Michigan 49506 —
Not listed Kalamazoo Michigan 49007 —
Not listed Pontiac Michigan 48341 —
Not listed Roseville Michigan 48066 —
Not listed Rochester Minnesota 55905 —
Not listed St Louis Missouri 63110 —
Not listed Las Vegas Nevada 89106 —
Not listed Reno Nevada 89511 —
Not listed Eatontown New Jersey 07724 —
Not listed Voorhees Township New Jersey 08043 —
Not listed Buffalo New York 14219 —
Not listed Laurelton New York 11413 —
Not listed Mineola New York 11501 —
Not listed New York New York 10021 —
Not listed New York New York 10032 —
Not listed Asheville North Carolina 28801 —
Not listed Chapel Hill North Carolina 27599 —
Not listed Charlotte North Carolina 28207 —
Not listed Winston-Salem North Carolina 27103 —
Not listed Fargo North Dakota 58102 —
Not listed Akron Ohio 44302 —
Not listed Cincinnati Ohio 45206 —
Not listed Cincinnati Ohio 45229 —
Not listed Cleveland Ohio 44106 —
Not listed Columbus Ohio 43210 —
Not listed Portland Oregon 97210 —
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 37923 —
Not listed Nashville Tennessee 37205 —
Not listed Nashville Tennessee 37232 —
Not listed Arlington Texas 76015 —
Not listed Houston Texas 77004 —
Not listed Houston Texas 77030 —
Not listed McAllen Texas 78503 —
Not listed Burlington Vermont 05401 —
Not listed Arlington Virginia 22207 —
Not listed Charlottesville Virginia 22908 —
Not listed Norfolk Virginia 23507 —
Not listed Wenatchee Washington 98801 —
Not listed Morgantown West Virginia 26506 —

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 129 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02251275, 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 Nov 27, 2019 · 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 NCT02251275 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →