Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00578695 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hyponatremia, sponsored by CardioKine.

Completed
Registry status
Phase 3
Development phase
652
Enrollment target
20
Study locations

NCT00578695 is a Phase 3 study of Hyponatremia that has completed, run by CardioKine. The registered enrollment target is 652 participants, above the 120-participant average among 3 other Hyponatremia trials with a reported enrollment target (443% higher). The trial reports 20 study locations across 6 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00578695, a Phase 3 study of Hyponatremia, has completed, sponsored by CardioKine.

COMPLETED
Registry status
Phase 3
Development phase
652 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Placebo
  • DRUG lixivaptan

Study Locations (20)

California

  • Research Site 1 - Bakersfield
  • Research Site 1 - Banning
  • Research Site 1 - Glendale
  • Research Site - Glendale
  • Research Site 1 - Los Angeles
  • Research Site 1 - Mission Viejo
  • Research Site 1 - Roseville
  • Research Site 1 - San Diego
  • Research Site 1 - San Diego

Florida

  • Research Site 1 - Bay Pines
  • Research Site 1 - Fort Lauderdale
  • Research Site 1 - Gainesville
  • Research Site 1 - Jacksonville
  • Research Site 1 - Jacksonville

Alabama

  • Research Site 1 - Birmingham
  • Research Site 1 - Birmingham
  • Research Site 1 - Mobile

Colorado

  • Research Site 1 - Aurora

Delaware

  • Research Site 1 - Newark

District of Columbia

  • Research Site 1 - Washington D.C.

Trial Details

FieldValue
Enrollment Target 652 participants
Start Date 2007-01
Phase Phase 3

Sponsor

CardioKine

6 total trials

What the Registry Record Tells You About NCT00578695

The ClinicalTrials.gov registry entry for NCT00578695 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 652 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 120-participant average among 3 other Hyponatremia trials with a reported enrollment target (443% higher). The listed sponsor is CardioKine, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hyponatremia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00578695 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT00578695 about?

NCT00578695 is a clinical study titled "THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation". 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.

What is the current status of trial NCT00578695?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2007-01.

What conditions does trial NCT00578695 study?

This clinical trial studies the following conditions: Hyponatremia.

What interventions are being tested in trial NCT00578695?

The interventions under investigation include: Placebo (DRUG), lixivaptan (DRUG).

Who is sponsoring clinical trial NCT00578695?

This trial is sponsored by CardioKine, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00578695 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hyponatremia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.