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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Tolvaptan Tablets Clear all
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 13, 2018 · Synced Sep 5, 2026, 10:02 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 6, 2026 · Synced Sep 5, 2026, 10:02 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 29, 2014 · Synced Sep 5, 2026, 10:02 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 26, 2016 · Synced Sep 5, 2026, 10:02 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 27, 2016 · Synced Sep 5, 2026, 10:02 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 26, 2018 · Synced Sep 5, 2026, 10:02 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 2, 2012 · Synced Sep 5, 2026, 10:02 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 7, 2018 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 2 Interventional Results available

Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT00413777
View directory record Official record
Conditions
Polycystic Kidney, Autosomal Dominant
Interventions
Tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2010
U.S. locations
11
States / cities
Denver, Colorado • Jacksonville, Florida • Atlanta, Georgia + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2017 · Synced Sep 5, 2026, 10:02 PM EDT
Terminated Phase 3 Interventional Results available

An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

NCT02020278
View directory record Official record
Conditions
Hyponatremia
Interventions
Tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
4 Years to 18 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
11
States / cities
Aurora, Colorado • Washington D.C., District of Columbia • Atlanta, Georgia + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 16, 2020 · Synced Sep 5, 2026, 10:02 PM EDT
Not yet 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 Jul 22, 2026 · Synced Sep 5, 2026, 10:02 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 6, 2012 · Synced Sep 5, 2026, 10:02 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 24, 2021 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 3 Interventional

EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan

NCT00071331
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
3,600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
161
States / cities
Birmingham, Alabama • Huntsville, Alabama • Mobile, Alabama + 131 more
Source: ClinicalTrials.gov public record
Updated May 2, 2012 · Synced Sep 5, 2026, 10:02 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 27, 2011 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 4 Interventional Results available

Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure

NCT02606253
View directory record Official record
Conditions
Heart Failure
Interventions
tolvaptan, Chlorothiazide, Metolazone
Drug
Lead sponsor
Vanderbilt University
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Nov 7, 2019 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02251275
View directory record Official record
Conditions
Polycystic Kidney, Autosomal Dominant
Interventions
Tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,803 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
81
States / cities
Birmingham, Alabama • Huntsville, Alabama • Mobile, Alabama + 70 more
Source: ClinicalTrials.gov public record
Updated Nov 26, 2019 · Synced Sep 5, 2026, 10:02 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 11, 2016 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 3 Interventional

"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia

NCT00072683
View directory record Official record
Conditions
Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
Interventions
tolvaptan, placebo matching tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
23
States / cities
Los Angeles, California • San Francisco, California • Denver, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 4 Interventional Results available

Tolvaptan for Ascites in Cirrhotic Patients

NCT01292304
View directory record Official record
Conditions
Ascites, Cirrhosis
Interventions
Tolvaptan
Drug
Lead sponsor
University of Florida
Other
Eligibility
18 Years to 70 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Jul 26, 2015 · Synced Sep 5, 2026, 10:02 PM EDT
Completed Phase 3 Interventional Results available

Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT00428948
View directory record Official record
Conditions
Polycystic Kidney Disease, Autosomal Dominant
Interventions
Tolvaptan, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
1,445 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
30
States / cities
Mobile, Alabama • Riverside, California • Stanford, California + 23 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2017 · Synced Sep 5, 2026, 10:02 PM EDT