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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00492037
• Date of registration: 25/06/2007
• Prospective Registration: No
• Primary sponsor: Cumberland Pharmaceuticals
• Public title: Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
• Scientific title: A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
• Date of first enrolment: January 2000
• Target sample size: 83
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00492037
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Finland, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Contacts

• Name: Art Wheeler, MD
• Affiliation: Cumberland Pharmaceuticals Inc.

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hyponatremia

Intervention(s)

Drug: YM087 oral

Primary Outcome(s)

Change in serum sodium from Baseline Safety of each dosing regimen [Time Frame: Beginning through end of treatment]

Secondary ID(s)

087-CL-043

1025-023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parke-Davis