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Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

NCT00660959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2011-06-28

No results posted yet for this study

Summary

The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.

Conditions

  • Hyponatremia With Normal Extracellular Fluid Volume

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
2008-04-30
Primary Completion
2010-06-30

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • India
  • Poland

Study Locations

More Related Trials

Entities

Drugs
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 NCT00660959 on ClinicalTrials.gov