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.
Phase I Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, liver cirrhosis with ascites (LCWA) and syndrome of inappropriate antidiuretic hormone (SIADH). Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH)and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan resulted in correction in hyponatremia together with a marked aquaresis in subject with volume overload. 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 SIDH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
oral capsule
oral capsule
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
Time frame: 60 days
Change from baseline in serum sodium on Day 30
Time frame: 60 days
Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L)
Time frame: 60 days
Time to first normalization of serum sodium (Na+≥135 mEq/L)
Time frame: 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site 1
Mobile, Alabama, United States
PsyPharma Global
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site 1
Los Angeles, California, United States
Research Site 1
Roseville, California, United States
Research Site
Aurora, Colorado, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Healthcare Clinical Data, Inc
North Miami, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Research Site
Augusta, Georgia, United States
...and 61 more locations