Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
NCT01240668 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240668
The ClinicalTrials.gov registry entry for NCT01240668 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,028 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka America Pharmaceutical, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Euvolemic Hyponatremia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01240668 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01240668?
This trial is sponsored by Otsuka America Pharmaceutical, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.