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

NCT ID: NCT00876876

Last Updated: 2010-11-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-12-31

Brief 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

Hypervolemic Hyponatremia

Keywords

hypervolemic hyponatremia; serum sodium; fluid overload; heartfailure; acute heart failure; vasopressin antagonist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo QD or BID

Placebo QD or BID

Group Type: PLACEBO_COMPARATOR

Lixivaptan

Intervention Type: DRUG

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.

Lixivaptan QD or BID

Lixivaptan QD or BID

Group Type: EXPERIMENTAL

Lixivaptan

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men and Women with age greater than or equal to 18 years.

2. 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:

• Patient completed full course of treatment (e.g., either placebo or lixivaptan). Treatment assignments for Protocol CK-LX3401 will not be unblinded prior to participation in the extension study.
• Baseline serum sodium concentration < 135 mEq/L following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. Repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.

3. The patient has clinical evidence of volume overload with at least one of the following:

• Dyspnea
• Pulmonary congestion (rales)
• Peripheral edema
• Increased jugular venous pressure and/or hepatic congestion with ascites
• Chest x-ray consistent with CHF; OR
• Plasma BNP ≥150 pg/mL or NT pro-BNP ≥ 450 pg/mL

Exclusion Criteria

1. 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.

2. Inability to provide informed consent.

3. Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).

4. Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).

5. Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.

6. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiokine Biopharma, LLC

INDUSTRY

Sponsor Role: collaborator

Biogen

INDUSTRY

Sponsor Role: collaborator

CardioKine Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Cardiokine Biopharma, LLC

Other Identifiers

CK-LX3422

Identifier Type: -

Identifier Source: org_study_id