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THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

NCT00578695 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2011-06-28

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.

Conditions

Interventions

DRUG

lixivaptan

Oral Capsule

DRUG

Placebo

Oral Capsule

Sponsors & Collaborators

  • Cardiokine Biopharma, LLC

    collaborator INDUSTRY

  • Biogen

    collaborator INDUSTRY

  • CardioKine Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-06-30

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Czechia
  • Germany
  • India
  • Israel
  • Italy
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00578695 on ClinicalTrials.gov