Trials / Completed
CompletedNCT01056848
International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 135 (actual)
- Sponsor
- CardioKine Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic 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 patients with hyponatremia.
Conditions
- Hyponatremia With Normal Extracellular Fluid Volume
- Hyponatremia With Excess Extracellular Fluid Volume
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2011-06-01
- First posted
- 2010-01-26
- Last updated
- 2011-06-21
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01056848. Inclusion in this directory is not an endorsement.