A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Euvolemia; Hypervolemia; Hyponatremia

Treatments: Drug: placebo; Drug: Conivaptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435591

087-CL-084

Details and patient eligibility

About

The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has a serum sodium value between 115 and 133 mEq/L
• Subject is euvolemic or hypervolemic

Exclusion criteria

• Clinical evidence of volume depletion or dehydration
• Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 4 patient groups

Dose Regimen 1

Experimental group

Description:

Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule

Treatment:

Drug: Conivaptan

Drug: placebo

Dose Regimen 2

Experimental group

Description:

Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule

Treatment:

Drug: Conivaptan

Dose Regimen 3

Experimental group

Description:

Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag

Treatment:

Drug: Conivaptan

Drug: placebo

Dose Regimen 4

Experimental group

Description:

Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag

Treatment:

Drug: Conivaptan