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Sponsored by: |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Information provided by: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT00132886 |
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
Condition | Intervention | Phase |
Heart Failure, Congestive |
Drug: tolvaptan |
Phase II |
MedlinePlus related topics: | Heart Failure |
Drug Information available for: | Tolvaptan |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure |
Estimated Enrollment: | 140 |
Study Start Date: | December 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 31 Study Locations |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Study Chair: | James Udelson, MD | Cardiovascular Clinical Studies and Tufts/New England Medical Center |
Study ID Numbers: | 156-04-247 |
First Received: | August 18, 2005 |
Last Updated: | June 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00132886 |
Health Authority: | United States: Food and Drug Administration |
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