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History of Changes for Study: NCT00435591
A Study to Assess the Safety and Effectiveness of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic Hyponatremia
Latest version (submitted April 30, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 14, 2007 None (earliest Version on record)
2 March 19, 2007 Study Status, Contacts/Locations and Study Identification
3 April 20, 2007 Study Status and Contacts/Locations
4 May 24, 2007 Contacts/Locations, Study Status and Study Design
5 June 15, 2007 Outcome Measures, Study Status, Arms and Interventions, Conditions, Study Description and Oversight
6 June 28, 2007 Contacts/Locations and Study Status
7 December 23, 2007 Arms and Interventions, Contacts/Locations, Study Status, Outcome Measures, Study Design, Conditions, Sponsor/Collaborators and Study Identification
8 July 9, 2008 Contacts/Locations, Arms and Interventions, Study Status, Conditions, Study Description, Eligibility, Outcome Measures and Study Identification
9 September 24, 2008 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 April 28, 2010 Outcome Measures, Study Status, Arms and Interventions, Results, References and Sponsor/Collaborators
11 June 7, 2010 Outcome Measures and Study Status
12 April 15, 2011 Study Status, Outcome Measures and References
13 April 30, 2014 Sponsor/Collaborators, Contacts/Locations, Study Status, Study Identification and Baseline Characteristics
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Study NCT00435591
Submitted Date:  February 14, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 087-CL-084
Brief Title: A Study to Assess the Safety and Effectiveness of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic Hyponatremia
Official Title: A Phase 4, Randomized, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic Hyponatremia
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2007
Overall Status: Recruiting
Study Start: January 2007
Primary Completion:
Study Completion:
First Submitted: February 14, 2007
First Submitted that
Met QC Criteria:
February 14, 2007
First Posted: February 15, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 14, 2007
Last Update Posted: February 15, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Astellas Pharma Inc
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic hyponatremia
Detailed Description:
Open or close this module Conditions
Conditions: Hyponatremia
Euvolemic
Keywords: Hyponatremia
Euvolemic
Conivaptan
Vaprisol®
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 120
Open or close this module Arms and Interventions
Intervention Details:
Drug: Conivaptan
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary safety variable is Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens
2. Safety variable: Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens
Secondary Outcome Measures:
1. Change from baseline in serum Na at each time point over the 48 hour treatment period and 7 day follow-up period,Baseline-adjusted AUC in serum Na over the first 24 hour treatment period, the 48 hour treatment period, and the 7 day follow-up period
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Subject has a serum sodium value between 115 and 130 mEq/L
  • Subject is euvolemic

Exclusion Criteria:

  • Subject has congestive heart failure
  • Clinical evidence of volume depletion or dehydration
  • Clinical evidence of hypervolemia
  • Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment
Open or close this module Contacts/Locations
Central Contact Person: Astellas Pharma US Medical Information
Telephone: 800-727-7003
Email: clintrials.info@us.astellas.com
Study Officials: Astellas
Study Director
Astellas Pharma US, Inc.
Locations: United States, South Carolina
[Recruiting]
Charleston, South Carolina, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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