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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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