NCT00876798

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: CardioKine Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.

Detailed description

Phase I and 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, LCWA, and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in subjects with hyponatremia.

Conditions

• Euvolemic Hyponatremia

Interventions

Type	Name	Description
DRUG	Lixivaptan	Capsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
DRUG	Placebo	Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-11-01
• First posted: 2009-04-07
• Last updated: 2011-06-28

Locations

90 sites across 8 countries: United States, Belgium, Czechia, India, Israel, Italy, Mexico, Peru