WithdrawnPhase 3

International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

Stopped: Created Extension study - This study was no longer feasible

300 participantsStarted 2009-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men and Women with age greater than or equal to 18 years.
✓. Prior successful participation in a randomized, blinded, placebo-controlled Phase 3 lixivaptan study of hyponatremia in Heart Failure (Protocol CK-LX3401) with evidence of continued need for therapy as follows:
✓. The patient has clinical evidence of volume overload with at least one of the following:

Exclusion criteria

✕. Women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
✕. Inability to provide informed consent.
✕. Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
✕. Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
✕. Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
✕. Euvolemic Hyponatremia (e.g., SIADH, etc.). Euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.

What they're measuring

Timeframe: 12 weeks

Trial details

NCT IDNCT00876876

SponsorCardioKine Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

View on ClinicalTrials.gov More Hypervolemic Hyponatremia trials