Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00876876
Other study ID # CK-LX3422
Secondary ID
Status Withdrawn
Phase Phase 3
First received April 3, 2009
Last updated November 19, 2010
Start date July 2009
Est. completion date December 2010

Study information

Verified date November 2010
Source CardioKine Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 300
Est. completion date December 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
CardioKine Inc. Biogen, Cardiokine Biopharma, LLC

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks Yes
Secondary To demonstrate that after 12 weeks of open-label lixivaptan treatment, improvements in the time to complete the Trail Making Test (Part B) will be maintained in patients continuing to receive lixivaptan. 20 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT01240668 - Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia N/A