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ClinicalTrials.gov public records Last synced Sep 30, 2026, 9:17 PM EDT

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Showing 1–24 of 42 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Tolvaptan (OPC-41061) Clear all
Completed Phase 4 Interventional Results available

Tolvaptan in Hyponatremic Cancer Patients

NCT01199198
View directory record Official record
Conditions
Advanced Cancers
Interventions
Tolvaptan, Placebo
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 23, 2020 · Synced Sep 30, 2026, 9:17 PM EDT
Withdrawn Not applicable Interventional

Fractional Urate Excretion in Nonedematous Hyponatremia

NCT01425125
View directory record Official record
Conditions
Cerebral Hyponatremia, SIADH, Cerebral Salt-wasting Syndrome, Reset Hypothalamic Osmostat
Interventions
Tolvaptan in euvolemic hyponatremia
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
Mineola, New York
Source: ClinicalTrials.gov public record
Updated Feb 6, 2019 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 2 Interventional

Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration

NCT05190744
View directory record Official record
Conditions
Autosomal Dominant Polycystic Kidney Disease, Nephrogenic Diabetes Insipidus, Acquired Nephrogenic Diabetes Insipidus, Congenital Nephrogenic Diabetes Insipidus
Interventions
PB
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated Jan 27, 2026 · Synced Sep 30, 2026, 9:17 PM EDT
Terminated No phase listed Observational

Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients

NCT02215148
View directory record Official record
Conditions
Brain Injury, Hyponatremia
Interventions
Tolvaptan
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
3
States / cities
St Louis, Missouri • Chapel Hill, North Carolina • Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Sep 8, 2016 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact

NCT01261481
View directory record Official record
Conditions
Healthy
Interventions
Tolvaptan
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 40 Years
Enrollment
29 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 7, 2012 · Synced Sep 30, 2026, 9:17 PM EDT
Terminated Phase 3 Interventional Results available

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia

NCT01227512
View directory record Official record
Conditions
Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
Interventions
tolvaptan, Fluid Restriction
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
56
States / cities
Birmingham, Alabama • Mobile, Alabama • Azusa, California + 46 more
Source: ClinicalTrials.gov public record
Updated Oct 30, 2014 · Synced Sep 30, 2026, 9:17 PM EDT
Terminated Not applicable Interventional

Tolvaptan for Patients With Acute Neurological Injuries

NCT02545114
View directory record Official record
Conditions
Hyponatremia, SIADH
Interventions
Tolvaptan
Drug
Lead sponsor
Polderman, Kees, H., MD, PhD
Individual
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
2
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 24, 2018 · Synced Sep 30, 2026, 9:17 PM EDT
Withdrawn Phase 4 Interventional

The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study

NCT01663662
View directory record Official record
Conditions
Heart Failure
Interventions
Tolvaptan, placebo
Drug
Lead sponsor
University of Michigan
Other
Eligibility
18 Years to 99 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Dec 11, 2015 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 3 Interventional Results available

Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients

NCT00550459
View directory record Official record
Conditions
Hyponatremia
Interventions
Tolvaptan, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
50 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
12
States / cities
Hawthorne, California • Vista, California • Colorado Springs, Colorado + 9 more
Source: ClinicalTrials.gov public record
Updated Apr 28, 2011 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 2 Interventional

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

NCT00132886
View directory record Official record
Conditions
Heart Failure, Congestive
Interventions
tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
26
States / cities
Huntsville, Alabama • Merced, California • Sylmar, California + 21 more
Source: ClinicalTrials.gov public record
Updated May 3, 2012 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 4 Interventional

Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure

NCT01863511
View directory record Official record
Conditions
Acute Decompensated Heart Failure
Interventions
loop diuretic, tolvaptan, ultrafiltration
Drug · Procedure
Lead sponsor
The Christ Hospital
Other
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 28, 2016 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 3 Interventional

Effect of Tolvaptan on Cognitive Function in Cirrhosis

NCT01556646
View directory record Official record
Conditions
Cirrhosis, Hepatic Encephalopathy, Hyponatremia
Interventions
Tolvaptan
Drug
Lead sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Federal
Eligibility
18 Years to 75 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Feb 7, 2014 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 2 Interventional Results available

8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT01451827
View directory record Official record
Conditions
Autosomal Dominant Polycystic Kidney Disease
Interventions
Tolvaptan MR, Tolvaptan IR, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
178 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
35
States / cities
Huntsville, Alabama • Mobile, Alabama • Peoria, Arizona + 31 more
Source: ClinicalTrials.gov public record
Updated Sep 27, 2018 · Synced Sep 30, 2026, 9:17 PM EDT
Completed No phase listed Observational

Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

NCT05408104
View directory record Official record
Conditions
Heart Failure, Heart Assist Device, Hyponatremic
Interventions
tolvaptan
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jun 7, 2022 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

V2 Receptor Effects on Fluid Regulation and Performance

NCT02084797
View directory record Official record
Conditions
Electrolyte Imbalance, Hyponatremia, Hypernatremia
Interventions
V2R (Vasopressin 2 receptor)
Drug
Lead sponsor
Oakland University
Other
Eligibility
18 Years to 60 Years
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
1
States / cities
Rochester, Michigan
Source: ClinicalTrials.gov public record
Updated May 12, 2016 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

NCT02160145
View directory record Official record
Conditions
Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
Interventions
Tolvaptan (OPC-41061), Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,370 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
82
States / cities
Birmingham, Alabama • Huntsville, Alabama • Mobile, Alabama + 73 more
Source: ClinicalTrials.gov public record
Updated Aug 8, 2018 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 2 Interventional Results available

Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD

NCT01210560
View directory record Official record
Conditions
Autosomal Dominant Polycystic Kidney Disease
Interventions
Tolvaptan MR, Tolvaptan IR
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
6
States / cities
Boston, Massachusetts • Minneapolis, Minnesota • Rochester, Minnesota + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2018 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 4 Interventional Results available

Pilot Study of Using Copeptin to Predict Response to Tolvaptan

NCT01346072
View directory record Official record
Conditions
Cardiovascular Diseases, Heart Diseases, Heart Failure
Interventions
tolvaptan
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated May 17, 2017 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 3 Interventional

Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management

NCT01584557
View directory record Official record
Conditions
Heart Failure
Interventions
Tolvaptan or Samsca, placebo or sugar pill
Drug
Lead sponsor
Cardiovascular Clinical Sciences Inc
Industry
Eligibility
18 Years and older
Enrollment
250 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
37
States / cities
Birmingham, Alabama • Huntsville, Alabama • Los Angeles, California + 34 more
Source: ClinicalTrials.gov public record
Updated Sep 27, 2016 · Synced Sep 30, 2026, 9:17 PM EDT
Recruiting Phase 2 Interventional

Bempedoic Acid Therapy for Polycystic Kidney Disease

NCT07282821
View directory record Official record
Conditions
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Interventions
Bempedoic Acid 180 MG Oral Tablet, Placebo Capsule(s)
Drug
Lead sponsor
Kenneth Hallows
Other
Eligibility
18 Years to 60 Years
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
3
States / cities
Baltimore, Maryland • Boston, Massachusetts • Burlington, Vermont
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 2 Interventional

Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients

NCT00043758
View directory record Official record
Conditions
Congestive Heart Failure
Interventions
Tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
170 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2004
U.S. locations
35
States / cities
Tucson, Arizona • Little Rock, Arkansas • San Diego, California + 30 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2005 · Synced Sep 30, 2026, 9:17 PM EDT
Recruiting Phase 3 Interventional

A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

NCT04782258
View directory record Official record
Conditions
Autosomal Recessive Polycystic Kidney (ARPKD)
Interventions
Tolvaptan Suspension, Tolvaptan Tablets
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
28 Days to 18 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
12
States / cities
Washington D.C., District of Columbia • Atlanta, Georgia • Chicago, Illinois + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2026 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Effects of Tolvaptan in Healthy Adults

NCT01973140
View directory record Official record
Conditions
Healthy
Interventions
Tolvaptan, Hypertonic saline infusion
Drug
Lead sponsor
Northwestern University
Other
Eligibility
21 Years to 55 Years · Male only
Enrollment
17 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2016
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 28, 2016 · Synced Sep 30, 2026, 9:17 PM EDT
Completed Phase 3 Interventional Results available

Tolvaptan Extension Study in Participants With ADPKD

NCT01214421
View directory record Official record
Conditions
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Interventions
Tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,083 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
38
States / cities
Mobile, Alabama • Peoria, Arizona • Tempe, Arizona + 33 more
Source: ClinicalTrials.gov public record
Updated Oct 25, 2021 · Synced Sep 30, 2026, 9:17 PM EDT