Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00043758
Other study ID # 156-01-232
Secondary ID
Status Completed
Phase Phase 2
First received August 13, 2002
Last updated June 23, 2005
Start date July 2002
Est. completion date July 2004

Study information

Verified date June 2005
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF)


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date July 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility History of congestive heart failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tolvaptan


Locations

Country Name City State
Canada London Health Sciences Center London Ontario
Canada Health Sciences Center Memorial University of Newfoundland St. John's Newfoundland and Labrador
Canada St. Michael's Hospital Toronto Ontario
Canada The Toronto Hospital Toronto Ontario
Canada Health Sciences Center Winnipeg Manitoba
United States Androscoggin Cardiology Associates Auburn Maine
United States Cardiovascular Associates of Augusta, PA Augusta Georgia
United States Ralph H. Johnson VAMC Charleston South Carolina
United States The Lindner Clinical Trial Center Cincinnati Ohio
United States Midwest Cardiology Research Foundation Columbus Ohio
United States Georgia Heart Specialists Covington Georgia
United States University of Colorado Denver Colorado
United States Harper Hospital/Wayne State University Detroit Michigan
United States John Dingell VA Medical Center Detroit Michigan
United States Cardiology Associates of Fort Lauderdale Fort Lauderdale Florida
United States The Hoffman Heart Institute of CT/St. Francis Hospital Hartford Connecticut
United States Pentucket Medical Associates Haverhill Massachusetts
United States The Care Group, LLC Indianapolis Indiana
United States Arkansas Heart Little Rock Arkansas
United States North Ohio Research LTD Lorraine Ohio
United States Mystic Cardiology Associates, Inc. Medford Massachusetts
United States Stern Cardiovascular Center Memphis Tennessee
United States Cardiovascular Research Center of South Florida Miami Florida
United States Yale University New Haven Connecticut
United States St. Luke's-Roosevelt Hospital Center New York New York
United States Illinois Heart and Lung Associates, SC Normal Illinois
United States Medical College of Pennsylvania Philadelphia Pennsylvania
United States Charlotte Heart Group Port Charlotte Florida
United States Maine Cardiology Associates Portland Maine
United States Miriam Hospital Providence Rhode Island
United States University Cardiology Foundation Providence Rhode Island
United States San Diego Cardiac Center San Diego California
United States North Ohio Research LTD. Sandusky Ohio
United States Northern California Medical Associates Santa Rosa California
United States Guthrie Clinic, LTD Sayre Pennsylvania
United States Medical Research Institute Slidell Louisiana
United States The Heart and Vascular Institute of Florida St. Petersburg Florida
United States Desert Cardiology of Tucson Tucson Arizona
United States Cardiovascular Consultants Medical Group, Inc. Walnut Creek California
United States South Bay Cardiovascular Associates West Islip New York

Sponsors (1)

Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

See also
  Status Clinical Trial Phase
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Terminated NCT05594940 - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting NCT04982081 - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection Phase 1
Completed NCT04394754 - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure N/A
Active, not recruiting NCT01385176 - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) N/A
Not yet recruiting NCT05516290 - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Completed NCT02885636 - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial Phase 3
Terminated NCT02788656 - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan) Phase 4
Completed NCT02252757 - Assess Measurements of Wireless Cardiac Output Device N/A
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Withdrawn NCT00346177 - Stem Cell Study for Patients With Heart Failure Phase 2
Active, not recruiting NCT01058837 - SCD-HeFT 10 Year Follow-up N/A
Completed NCT00957541 - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device Phase 2