Tolvaptan

Generic Name: Tolvaptan

Brand Names: Jinarc, Jynarque 45/15 Carton, Samsca, Tolvaptan Accord, Xeljanz

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₅ClN_₂O_₃

CAS Number: 150683-30-0

Unique Ingredient Identifier: 1E2497LPNY

Background: Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.

Indication: Treatment of symptomatic and resistant to fluid restriction euvolemic or hypervolemic hyponatremia associated with congestive heart failure, SIADH, and cirrhosis.

Associated Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD), Symptomatic euvolemic Hyponatremia, Symptomatic hypervolemic Hyponatremia

Associated Therapies: -

Clinical Trials

Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Phase 1

Completed

Conditions: Psoriasis
Immunomodulation

Interventions: Drug: tofacitinib

First Posted Date: 2012-11-29

Last Posted Date: 2013-02-20

Lead Sponsor: Pfizer

Target Recruit Count: 59

Registration Number: NCT01736696

Locations: 🇺🇸
Pfizer Investigational Site, Little Rock, Arkansas, United States

Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)

Phase 3

Withdrawn

Conditions: Acute Heart Failure

Interventions: Drug: Tolvaptan
Drug: placebo

First Posted Date: 2012-11-26

Last Posted Date: 2024-11-20

Lead Sponsor: Maisel, Alan, M.D.

Target Recruit Count: 350

Registration Number: NCT01733134

Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites

Phase 4

Conditions: Hyponatremia
Ascites

Interventions: Drug: placebo
Drug: Tolvaptan

First Posted Date: 2012-10-30

Last Posted Date: 2012-10-30

Lead Sponsor: Konkuk University Medical Center

Target Recruit Count: 105

Registration Number: NCT01716611

Locations: 🇰🇷
Konkuk University Medical Center, Seoul, Korea, Republic of

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

Phase 4

Withdrawn

Conditions: Heart Failure

Interventions: Drug: placebo
Drug: Tolvaptan

First Posted Date: 2012-08-13

Last Posted Date: 2015-12-11

Lead Sponsor: University of Michigan

Registration Number: NCT01663662

Locations: 🇺🇸
University of Michigan Health Systems, Ann Arbor, Michigan, United States

Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema

Phase 3

Completed

Conditions: Cardiac Edema

Interventions: Drug: Placebo
Drug: Tolvaptan

First Posted Date: 2012-07-26

Last Posted Date: 2013-12-30

Lead Sponsor: Otsuka Beijing Research Institute

Target Recruit Count: 244

Registration Number: NCT01651156

Locations: 🇨🇳
Zhejiang Hospital, Hangzhou, Zhejiang, China

Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

Phase 3

Completed

Conditions: Dyspnea
Heart Failure

Interventions: Drug: Placebo
Drug: Tolvaptan

First Posted Date: 2012-07-19

Last Posted Date: 2017-04-27

Lead Sponsor: Duke University

Target Recruit Count: 257

Registration Number: NCT01644331

Locations: 🇺🇸
Northeast Georgia Heart Center, Gainesville, Georgia, United States
🇺🇸
University of Colorado at Denver and Health Sciences Center, Aurora, Colorado, United States
🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States

and more 15 locations

Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)

Phase 2

Completed

Conditions: Cardiovascular Diseases
Nephropathy

Interventions: Drug: Placebo
Drug: Tolvaptan

First Posted Date: 2012-07-12

Last Posted Date: 2014-10-09

Lead Sponsor: Regional Hospital Holstebro

Target Recruit Count: 20

Registration Number: NCT01638663

Locations: 🇩🇰
Safa Therwani, Holstebro, Denmark

Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

Phase 3

Completed

Conditions: Cardiac-induced Edema

Interventions: Drug: Placebo
Drug: Tolvaptan

First Posted Date: 2012-06-13

Last Posted Date: 2015-06-02

Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd

Target Recruit Count: 85

Registration Number: NCT01618448

Locations: 🇨🇳
National Taiwan University Hospita, Taipei, Taiwan

Effect of Tolvaptan on Cognitive Function in Cirrhosis

Phase 3

Completed

Conditions: Hepatic Encephalopathy
Hyponatremia
Cirrhosis

Interventions: Drug: Tolvaptan

First Posted Date: 2012-03-16

Last Posted Date: 2014-02-07

Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Target Recruit Count: 25

Registration Number: NCT01556646

Locations: 🇺🇸
Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, United States

Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites

Phase 4

Terminated

Conditions: Hyponatremia and Extracellular Fluid in Cirrhotic

Interventions: Drug: Tolvaptan
Drug: Placebo

First Posted Date: 2012-03-13

Last Posted Date: 2022-03-04

Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 74

Registration Number: NCT01552590

Locations: 🇰🇷
Soonchunhyang Univ. Bucheon Hospital, Bucheon, Korea, Republic of
🇰🇷
Hallym Univ. Chuncheon Sacred Heart Hospital, Bucheon, Korea, Republic of
🇰🇷
Wonju Christian Hospital, Wonju, Korea, Republic of

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