Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hyponatremia

Treatments: Drug: Conivaptan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478192

087-CL-088

Details and patient eligibility

About

The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Euvolemic or hypervolemic (edematous) based on clinical presentation
• Serum sodium between 115 and 130mEq/L at baseline

Exclusion criteria

• Clinical presentation of volume depletion or dehydration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Regimen 1 Conivaptan QD

Experimental group

Description:

20 mg conivaptan once a day

Treatment:

Drug: Conivaptan

Regimen 2 Conivaptan BID

Experimental group

Description:

20 mg conivaptan two times a day

Treatment:

Drug: Conivaptan

Regimen 3 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo