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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 Jul 21, 2026, 6:50 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

Study identification

NCT ID
NCT02251275
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
1,803 participants

Conditions and interventions

Interventions

  • Tolvaptan Drug

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 16, 2014
Primary completion
Nov 8, 2018
Completion
Nov 8, 2018
Last update posted
Nov 26, 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 26, 2019 · Synced Jul 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 protocol, eligibility criteria, and contact information for NCT02251275 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →