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Completed Phase 3 Interventional Results available

Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients

ClinicalTrials.gov ID: NCT00550459

Public ClinicalTrials.gov record NCT00550459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Pilot, Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Effects of Titrated Oral Tolvaptan 15, 30, or 60 mg QD on Cognitive and Neurological Function in Elderly Hyponatremic Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.

Study identification

NCT ID
NCT00550459
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
57 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2007
Primary completion
Jan 31, 2009
Completion
Feb 28, 2009
Last update posted
Apr 27, 2011

2007 – 2009

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Sarah. S. Olelewe, MD Hawthorne California 90250
Progressive Clinical Research Vista California 92083
Pikes Peak Cardiology Colorado Springs Colorado 80907
Innovative Research of West FL Largo Florida 33770
Coastal Nephrology Assoc. Research Center Punta Gorda Florida 33950
Rockdale Medical Research Associates Conyers Georgia 30094
Otis Barnum, DO Natchitoches Louisiana 71457
Lillestol Research, LLC Fargo North Dakota 58106
Carolina Research Associates Columbia South Carolina 29201
Wayne O. Wells, MD Lebanon Tennessee 37087
Memorial Clinical Associates Houston Texas 77043
Mitchell Rosner, MD Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00550459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 27, 2011 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00550459 live on ClinicalTrials.gov.

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