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| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 13, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | May 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00043771 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients |
| Official Title ICMJE | Multi-Center, Double-Blind Study to Compare the Effects of 30mg Qd Versus 15 Mg Bid of Tolvaptan in Congestive Heart Failure Patients |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Condition ICMJE | Congestive Heart Failure |
| Intervention ICMJE | Drug: Tolvaptan |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 40 |
| Completion Date | September 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | History of CHF |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00043771 |
| Responsible Party | |
| Study ID Numbers ICMJE | 156-01-231 |
| Study Sponsor ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Verification Date | September 2002 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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