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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyponatremia

In brief

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

Key facts

Study ID

NCT00550459

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

57

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2011-04-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women and men 50 years of age or older.
• Serum Sodium ≥123 and ≤ 134 mEq/L [mmol/L]at screening and baseline.
• Subjects with serum sodium concentrations ≥118 and ≤122 mEq/L[mmol/L] at screening and baseline may be entered into the trial based on consultation and approval from the study medical monitor.

You may not qualify if…

• Conditions or history which may present a safety concern to the subject or their offspring or extreme susceptibility to hypotension with sudden fluid loss (aquaresis).
• Hyponatremia that is acute, easily reversible, artifactual, or due to a condition not associated with vasopressin excess or likely to respond to aquaretic therapy.
• Conditions associated with an independent imminent risk of morbidity and mortality.
• Conditions which may confound the assessment of endpoints, history of poor compliance, participation in a clinical trial believed by the PI or Sponsor likely to confound endpoint assessments.
• Conditions which may confound primary endpoints of cognitive function.

Where it is running

• Sarah. S. Olelewe, MD — Hawthorne, California, United States
• Progressive Clinical Research — Vista, California, United States
• Pikes Peak Cardiology — Colorado Springs, Colorado, United States
• Innovative Research of West FL — Largo, Florida, United States
• Coastal Nephrology Assoc. Research Center — Punta Gorda, Florida, United States
• Rockdale Medical Research Associates — Conyers, Georgia, United States
• Otis Barnum, DO — Natchitoches, Louisiana, United States
• Lillestol Research, LLC — Fargo, North Dakota, United States
• Carolina Research Associates — Columbia, South Carolina, United States
• Wayne O. Wells, MD — Lebanon, Tennessee, United States
• Memorial Clinical Associates — Houston, Texas, United States
• Mitchell Rosner, MD — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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