NCT00492037

Brief Summary

Study of efficacy \& safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2000

Geographic Reach
9 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

First QC Date

June 25, 2007

Last Update Submit

April 30, 2014

Conditions

Hyponatremia

Keywords

hyponatremiahypervolemiceuvolemicconivaptan

Outcome Measures

Primary Outcomes (1)

  • Change in serum sodium from Baseline Safety of each dosing regimen

    Beginning through end of treatment

Interventions

YM087 oralDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serum Sodium 115 to \<130mEq/L
  • Plasma Osmolarity \<290 mOsmol/kg H2O

You may not qualify if:

  • Significant renal insufficiency
  • Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Tournai, Belgium

Location

Unknown Facility

Jyväskylä, Finland

Location

Unknown Facility

Turku, Finland

Location

Unknown Facility

Garches, France

Location

Unknown Facility

Limoges, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Bad Nauheim, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dresdan, Germany

Location

Unknown Facility

Göttingen, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Ferrara, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Pisa, Italy

Location

Unknown Facility

Verona, Italy

Location

Unknown Facility

Delft, Netherlands

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Leiden, Netherlands

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Radomsko, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Córdoba, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Cardiff, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hyponatremia

Interventions

conivaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Art Wheeler, MD

    Cumberland Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

January 1, 2000

Study Completion

February 1, 2002

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations

FR(3)IT(4)PL(3)GB(2)FI(2)BE(3)DE(5)NL(4)ES(3)