Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00043771
First received: August 13, 2002
Last updated: June 23, 2005
Last verified: September 2002
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Purpose
Patients with congestive heart failure will be assessed for safety and clinical effects of Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.
| Condition | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Drug: Tolvaptan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Multi-Center, Double-Blind Study to Compare the Effects of 30mg Qd Versus 15 Mg Bid of Tolvaptan in Congestive Heart Failure Patients |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Tolvaptan
U.S. FDA Resources
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
History of CHF
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043771
Locations
| United States, California | |
| Central Cardiology Medical Clinic | |
| Bakersfield, California, United States | |
| University of California-San Diego | |
| San Diego, California, United States | |
| United States, Florida | |
| University of Miami/Jackson Memorial Hospital | |
| Miami, Florida, United States | |
| United States, Louisiana | |
| Medical Research Institute | |
| Slidell, Louisiana, United States | |
| United States, Maine | |
| Androscoggin Cardiology Associates | |
| Auburn, Maine, United States | |
| United States, Missouri | |
| University of Missouri-Kansas City School of Medicine | |
| Kansas City, Missouri, United States | |
| Saint Louis University | |
| St. Louis, Missouri, United States | |
| United States, Oklahoma | |
| Cardiology of Oklahoma | |
| Tulsa, Oklahoma, United States | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00043771 History of Changes |
| Other Study ID Numbers: | 156-01-231 |
| Study First Received: | August 13, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
CHF |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013