Trials / Withdrawn
WithdrawnNCT00876876
International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- CardioKine Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lixivaptan | Capsules containing 25, or 50 mg doses of oral lixivaptan to be administered BID or QD Lixivaptan will be administered for 12 weeks in the Open-Label Period which will be followed by a 4 week Randomized, Placebo-Controlled period. |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2010-08-01
- Completion
- 2010-12-01
- First posted
- 2009-04-07
- Last updated
- 2010-11-23
Source: ClinicalTrials.gov record NCT00876876. Inclusion in this directory is not an endorsement.