Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

NCT ID: NCT00492037

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2002-02-28

Brief Summary

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

Detailed Description

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Conditions

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Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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YM087 oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parke-Davis

INDUSTRY

Sponsor Role collaborator

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Art Wheeler, MD

Role: STUDY_DIRECTOR

Cumberland Pharmaceuticals, Inc.

Locations

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Brussels, , Belgium

Site Status

Liège, , Belgium

Site Status

Tournai, , Belgium

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Jyväskylä, , Finland

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Turku, , Finland

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Garches, , France

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Limoges, , France

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Paris, , France

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Bad Nauheim, , Germany

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Berlin, , Germany

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Dresdan, , Germany

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Göttingen, , Germany

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München, , Germany

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Ferrara, , Italy

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Pavia, , Italy

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Pisa, , Italy

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Verona, , Italy

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Delft, , Netherlands

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Groningen, , Netherlands

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Leiden, , Netherlands

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Nijmegen, , Netherlands

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Radomsko, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Barcelona, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Cardiff, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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Belgium Finland France Germany Italy Netherlands Poland Spain United Kingdom

Other Identifiers

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1025-023

Identifier Type: -

Identifier Source: secondary_id

087-CL-043

Identifier Type: -

Identifier Source: org_study_id

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