An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hyponatremia

Treatments: Drug: conivaptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379847

087-CL-080

Details and patient eligibility

About

This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serum sodium levels less than or equal 130mEq/L
• Euvolemic or Hypervolemic hyponatremia

Exclusion criteria

• Clinical evidence of volume depletion or dehydration
• Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
• Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

251 participants in 2 patient groups

1

Experimental group

Description:

Lower dose

Treatment:

Drug: conivaptan

2

Experimental group

Description:

Higher dose

Treatment:

Drug: conivaptan