Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure

Treatments: Drug: placebo; Drug: conivaptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00057356

087-CL-071

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients may be male or female age 18 years or older.
• Women must be post-menopausal or surgically sterile.
• Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Experimental group

Description:

Low dose

Treatment:

Drug: conivaptan

3

Experimental group

Description:

Middle dose

Treatment:

Drug: conivaptan

4

Experimental group

Description:

High dose

Treatment:

Drug: conivaptan