A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tole… (NCT00876798) | Clinical Trial Compass
CompletedPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
United States206 participantsStarted 2009-06
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Men or women aged 18 or older.
✓. Diagnosis of euvolemic hyponatremia (Na+ \< 135 mEq/L).
✓. Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
✓. In the Investigator's judgement the patient has adequate visual and auditory acuity to allow participation in the trial.
Exclusion criteria
✕. Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed.
✕. Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
✕. Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy).
✕. Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion.
✕. Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
✕. Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact).
✕
What they're measuring
1
To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.