Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safe… (NCT00660959) | Clinical Trial Compass
CompletedPhase 3
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
United States106 participantsStarted 2008-04
Plain-language summary
The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.
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 (120 ≤ Na+\<130 mEq/L)
* Hospitalized or willing to be admitted to a monitored setting for approximately the first 48 hours of treatment
Exclusion Criteria:
* Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed
* Symptomatic hyponatremia (e.g., lethargy, coma, seizures, changes in mental status attributable to hyponatremia)
* Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)
* Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion
* Hyponatremia as a result of any medication that can safely be withdrawn
* Hyponatremia due to hypothyroidism or adrenal insufficiency
* Diagnosis of psychogenic polydipsia
* Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or conivaptan
* Use of radiotherapy and chemotherapy within 2 wks of randomization
* Likely to require, or to receive IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study
* Supine systolic arterial blood pressure of ≤ 90 mmHg
* Serum creatinine \>3.0 mg/dL
* History of uncontrolled type 2 diabetes mellitus
* Severe pulmonary artery hypertension: patients whose condition is expected to deteriorate wit…
What they're measuring
1
Average daily area under the curve (AUC) of change from baseline in serum sodium concentrations up to 72 hrs in lixivaptan treated subjects compared to placebo