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Showing 1–17 of 17 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Tolvaptan or Samsca Clear all
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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM EDT
Completed Phase 4 Interventional Results available

Aquaresis Utility for Hyponatremic Acute Heart Failure Study

NCT02183792
View directory record Official record
Conditions
Heart Failure
Interventions
Tolvaptan, Furosemide
Drug
Lead sponsor
University of Southern California
Other
Eligibility
18 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
2
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated May 27, 2019 · Synced Sep 15, 2026, 3:06 AM EDT
Completed Phase 3 Interventional Results available

Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

NCT01644331
View directory record Official record
Conditions
Heart Failure, Dyspnea
Interventions
Tolvaptan, Placebo
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
257 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
18
States / cities
Aurora, Colorado • Atlanta, Georgia • Gainesville, Georgia + 14 more
Source: ClinicalTrials.gov public record
Updated Apr 26, 2017 · Synced Sep 15, 2026, 3:06 AM EDT
Terminated Phase 3 Interventional Results available

Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

NCT02012959
View directory record Official record
Conditions
Hyponatremia
Interventions
Tolvaptan
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
4 Weeks to 17 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
5
States / cities
Aurora, Colorado • Washington D.C., District of Columbia • New York, New York + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2018 · Synced Sep 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 26, 2026 · Synced Sep 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 27, 2016 · Synced Sep 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM 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 15, 2026, 3:06 AM EDT