Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00043758
Collaborator
(none)
170
40
24
4.3
0.2
Study Details
Study Description
Brief 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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date
:
Jul 1, 2002
Study Completion Date
:
Jul 1, 2004
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
History of congestive heart failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Desert Cardiology of Tucson | Tucson | Arizona | United States | 85741 |
| 2 | Arkansas Heart | Little Rock | Arkansas | United States | 72211 |
| 3 | San Diego Cardiac Center | San Diego | California | United States | 92123 |
| 4 | Northern California Medical Associates | Santa Rosa | California | United States | 95403 |
| 5 | Cardiovascular Consultants Medical Group, Inc. | Walnut Creek | California | United States | 94598 |
| 6 | University of Colorado | Denver | Colorado | United States | 80262 |
| 7 | The Hoffman Heart Institute of CT/St. Francis Hospital | Hartford | Connecticut | United States | 06105 |
| 8 | Yale University | New Haven | Connecticut | United States | 06510 |
| 9 | Cardiology Associates of Fort Lauderdale | Fort Lauderdale | Florida | United States | 33308 |
| 10 | Cardiovascular Research Center of South Florida | Miami | Florida | United States | 33173 |
| 11 | Charlotte Heart Group | Port Charlotte | Florida | United States | 33952 |
| 12 | The Heart and Vascular Institute of Florida | St. Petersburg | Florida | United States | 33701 |
| 13 | Cardiovascular Associates of Augusta, PA | Augusta | Georgia | United States | 30901 |
| 14 | Georgia Heart Specialists | Covington | Georgia | United States | 30014 |
| 15 | Illinois Heart and Lung Associates, SC | Normal | Illinois | United States | 61761 |
| 16 | The Care Group, LLC | Indianapolis | Indiana | United States | 46260 |
| 17 | Medical Research Institute | Slidell | Louisiana | United States | 70458 |
| 18 | Androscoggin Cardiology Associates | Auburn | Maine | United States | 04210 |
| 19 | Maine Cardiology Associates | Portland | Maine | United States | 04102 |
| 20 | Pentucket Medical Associates | Haverhill | Massachusetts | United States | 01839 |
| 21 | Mystic Cardiology Associates, Inc. | Medford | Massachusetts | United States | 02155 |
| 22 | Harper Hospital/Wayne State University | Detroit | Michigan | United States | 48201 |
| 23 | John Dingell VA Medical Center | Detroit | Michigan | United States | 48201 |
| 24 | St. Luke's-Roosevelt Hospital Center | New York | New York | United States | 10025 |
| 25 | South Bay Cardiovascular Associates | West Islip | New York | United States | 11795 |
| 26 | The Lindner Clinical Trial Center | Cincinnati | Ohio | United States | 45219 |
| 27 | Midwest Cardiology Research Foundation | Columbus | Ohio | United States | 43202 |
| 28 | North Ohio Research LTD | Lorraine | Ohio | United States | 44053 |
| 29 | North Ohio Research LTD. | Sandusky | Ohio | United States | 44870 |
| 30 | Medical College of Pennsylvania | Philadelphia | Pennsylvania | United States | 19129 |
| 31 | Guthrie Clinic, LTD | Sayre | Pennsylvania | United States | 18840 |
| 32 | Miriam Hospital | Providence | Rhode Island | United States | 02905 |
| 33 | University Cardiology Foundation | Providence | Rhode Island | United States | 02905 |
| 34 | Ralph H. Johnson VAMC | Charleston | South Carolina | United States | 29401 |
| 35 | Stern Cardiovascular Center | Memphis | Tennessee | United States | 38120 |
| 36 | Health Sciences Center | Winnipeg | Manitoba | Canada | R3A 1R9 |
| 37 | Health Sciences Center Memorial University of Newfoundland | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 38 | London Health Sciences Center | London | Ontario | Canada | N6A 4G5 |
| 39 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 40 | The Toronto Hospital | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00043758
Other Study ID Numbers:
- 156-01-232
First Posted:
Aug 14, 2002
Last Update Posted:
Jun 24, 2005
Last Verified:
Jun 1, 2005