Congestive Heart FailurePhase 2NCT00043758
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
A Phase 2 study testing Tolvaptan in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 40 sites in 2 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Tolvaptan
- How many people
- 170 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Jul 2002to Jul 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
History of congestive heart failure
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States35 sites
Androscoggin Cardiology Associates
Auburn, Maine, 04210
Cardiovascular Associates of Augusta, PA
Augusta, Georgia, 30901
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Midwest Cardiology Research Foundation
Columbus, Ohio, 43202
Georgia Heart Specialists
Covington, Georgia, 30014
University of Colorado
Denver, Colorado, 80262
Harper Hospital/Wayne State University
Detroit, Michigan, 48201
John Dingell VA Medical Center
Detroit, Michigan, 48201
Cardiology Associates of Fort Lauderdale
Fort Lauderdale, Florida, 33308
The Hoffman Heart Institute of CT/St. Francis Hospital
Hartford, Connecticut, 06105
Pentucket Medical Associates
Haverhill, Massachusetts, 01839
The Care Group, LLC
Indianapolis, Indiana, 46260
Arkansas Heart
Little Rock, Arkansas, 72211
North Ohio Research LTD
Lorraine, Ohio, 44053
Mystic Cardiology Associates, Inc.
Medford, Massachusetts, 02155
Stern Cardiovascular Center
Memphis, Tennessee, 38120
Cardiovascular Research Center of South Florida
Miami, Florida, 33173
Yale University
New Haven, Connecticut, 06510
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
Illinois Heart and Lung Associates, SC
Normal, Illinois, 61761
Medical College of Pennsylvania
Philadelphia, Pennsylvania, 19129
Charlotte Heart Group
Port Charlotte, Florida, 33952
Maine Cardiology Associates
Portland, Maine, 04102
Miriam Hospital
Providence, Rhode Island, 02905
University Cardiology Foundation
Providence, Rhode Island, 02905
San Diego Cardiac Center
San Diego, California, 92123
North Ohio Research LTD.
Sandusky, Ohio, 44870
Northern California Medical Associates
Santa Rosa, California, 95403
Guthrie Clinic, LTD
Sayre, Pennsylvania, 18840
Medical Research Institute
Slidell, Louisiana, 70458
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, 33701
Desert Cardiology of Tucson
Tucson, Arizona, 85741
Cardiovascular Consultants Medical Group, Inc.
Walnut Creek, California, 94598
South Bay Cardiovascular Associates
West Islip, New York, 11795
Canada5 sites
London Health Sciences Center
London, Ontario, N6A 4G5
Health Sciences Center Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3V6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
The Toronto Hospital
Toronto, Ontario, M5G 2C4
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9
About this study
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)
- Conditions
- Congestive Heart Failure
- Being tested
- Tolvaptan
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2002 (estimated)
- Study startJul 2002
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 170 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043758
- Sponsor's protocol ID
- 156-01-232
- Status last verified
- Jun 2005
- First submitted
- 13 Aug 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Udelson JE, McGrew FA, Flores E, Ibrahim H, Katz S, Koshkarian G, O'Brien T, Kronenberg MW, Zimmer C, Orlandi C, Konstam MA. Multicenter, randomized, double-blind, placebo-controlled study on the effect of oral tolvaptan on left ventricular dilation and function in patients with heart failure and systolic dysfunction. J Am Coll Cardiol. 2007 Jun 5;49(22):2151-9. doi: 10.1016/j.jacc.2007.01.091. Epub 2007 May 18.
PubMed 17543634
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00043758
- Acronym / sponsor ID
- 156-01-232
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Jul 2004
- First posted
- 14 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolvaptan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 17543634Udelson JE, McGrew FA, Flores E, Ibrahim H, Katz S, Koshkarian G, O'Brien T, Kronenberg MW, Zimmer C, Orlandi C, Konstam MA. Multicenter, randomized, double-blind, placebo-controlled study on the effect of oral tolvaptan on left ventricular dilation and function in patients with heart failure and systolic dysfunction. J Am Coll Cardiol. 2007 Jun 5;49(22):2151-9. doi: 10.1016/j.jacc.2007.01.091. Epub 2007 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolvaptan in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.