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NCT01240668 · ClinicalTrials.gov registry record
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
A clinical trial of Euvolemic Hyponatremia and Hypervolemic Hyponatremia, sponsored by Otsuka America Pharmaceutical.
- Completed
- Registry status
- 5,028
- Enrollment target
- 20
- Study locations
NCT01240668: Completed study of Euvolemic Hyponatremia and Hypervolemic Hyponatremia, sponsored by Otsuka America Pharmaceutical.
NCT01240668 is a study of Euvolemic Hyponatremia and Hypervolemic Hyponatremia that has completed, run by Otsuka America Pharmaceutical. The registered enrollment target is 5,028 participants. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240668, a study of Euvolemic Hyponatremia and Hypervolemic Hyponatremia, has completed, sponsored by Otsuka America Pharmaceutical.
- COMPLETED
- Registry status
- 5,028 participants
- Enrollment target
- 20
- Study locations
Study Summary
The registry is a multi-center, prospective, observational study designed to collect data in patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The registry is observational in design, and the registry will collect data on patients with a serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the duration of the hospital, from admission to discharge, and the data will be entered into the case report form (CRF) or into an electronic data capture (EDC) system. These patients will be entered into the registry over the duration of 18 months at community, tertiary, and academic medical centers from diverse multiple regions of the USA and Europe. A patient's treatment will be determined by their caregiver and not by this protocol. Thus, the registry will provide a unique opportunity to evaluate how the patients are managed under real-world management conditions.
Conditions Studied
Study Locations (20)
Florida
- Memorial Healthcare System - Hollywood
- Jacksonville Cardiovascular Center - Jacksonville
- Kidney & HTN Specialists of Miami - Miami
- Naples Community Hospital - Naples
- Florida Hospital - Orlando
- Coastal Nephrology Associates Research - Port Charlotte
California
- North America Research Institute - Azusa
- Chrishard Medical Group - Inglewood
- UCLA - Los Angeles
- Regional Cardiology Associates - Sacramento
Illinois
- Northwestern Memorial Hospital - Chicago
- Rush University Medical Center - Chicago
- Loyola University Medical Center - Maywood
Georgia
- St. Joseph's Hospital of Atlanta - Atlanta
- Joseph M Still Research Foundation, Inc - Augusta
Colorado
- Portercare Adventist Health System - Denver
District of Columbia
- Georgetown University Hospital - Washington D.C.
Kentucky
- Research Integrity, LLC - Owensboro
Louisiana
- Ochsner Multi-Organ Transplant Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,028 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-08 |
What the finished NCT01240668 record still lists
NCT01240668 is an observational study that tracks outcomes without assigning an intervention. Its 5,028 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Euvolemic Hyponatremia appearing as the primary indexed condition, and to 0 interventions.
NCT01240668 names 20 study sites across 9 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01240668 about?
NCT01240668 is a clinical study titled "Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia". The registry is a multi-center, prospective, observational study designed to collect data in patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Europe; patients wit...
What is the current status of trial NCT01240668?
This trial is currently completed. The enrollment target is 5,028 participants. The study started on 2010-09. Estimated completion is 2013-08.
What conditions does trial NCT01240668 study?
This clinical trial studies the following conditions: Euvolemic Hyponatremia, Hypervolemic Hyponatremia.
Who is sponsoring clinical trial NCT01240668?
This trial is sponsored by Otsuka America Pharmaceutical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01240668 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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