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NCT00578695 · ClinicalTrials.gov registry record · Phase 3
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
A Phase 3 study of Hyponatremia, sponsored by CardioKine.
- Completed
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
- 20
- Study locations
NCT00578695: Completed Phase 3 study of Hyponatremia, sponsored by CardioKine.
NCT00578695 is a Phase 3 study of Hyponatremia that has completed, run by CardioKine. The registered enrollment target is 652 participants, above the 120-participant average among 3 other Hyponatremia trials with a reported enrollment target (443% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578695, a Phase 3 study of Hyponatremia, has completed, sponsored by CardioKine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG lixivaptan
Study Locations (20)
California
- Research Site 1 - Bakersfield
- Research Site 1 - Banning
- Research Site 1 - Glendale
- Research Site - Glendale
- Research Site 1 - Los Angeles
- Research Site 1 - Mission Viejo
- Research Site 1 - Roseville
- Research Site 1 - San Diego
- Research Site 1 - San Diego
Florida
- Research Site 1 - Bay Pines
- Research Site 1 - Fort Lauderdale
- Research Site 1 - Gainesville
- Research Site 1 - Jacksonville
- Research Site 1 - Jacksonville
Alabama
- Research Site 1 - Birmingham
- Research Site 1 - Birmingham
- Research Site 1 - Mobile
Colorado
- Research Site 1 - Aurora
Delaware
- Research Site 1 - Newark
District of Columbia
- Research Site 1 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00578695 record still lists
NCT00578695 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 3 other Hyponatremia trials with a reported enrollment target (443% higher).
The record links to 1 condition, with Hyponatremia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00578695 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00578695 about?
NCT00578695 is a clinical study titled "THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation". The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
What is the current status of trial NCT00578695?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2007-01.
What conditions does trial NCT00578695 study?
This clinical trial studies the following conditions: Hyponatremia.
What interventions are being tested in trial NCT00578695?
The interventions under investigation include: Placebo (DRUG), lixivaptan (DRUG).
Who is sponsoring clinical trial NCT00578695?
This trial is sponsored by CardioKine, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00578695 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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