A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2007

Last Updated Date

September 24, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety variable: Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens
The primary safety variable is Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens

Change History

Complete list of historical versions of study NCT00435591 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in serum sodium Baseline-adjusted area under the curve (AUC) in serum sodium [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Official Title ^ICMJE

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 or Hypervolemic Hyponatremia

Brief Summary

The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hyponatremia
Euvolemia
Hypervolemia

Intervention ^ICMJE

Drug: Conivaptan
Drug: placebo

Study Arms / Comparison Groups

Experimental: placebo loading dose + ampoule
Experimental: active loading dose + ampoule
Experimental: placebo loading dose + premix bag
Experimental: active loading dose + premix bag

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

121

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has a serum sodium value between 115 and 133 mEq/L
Subject is euvolemic or hypervolemic

Exclusion Criteria:

Clinical evidence of volume depletion or dehydration
Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, India, Israel

Administrative Information

NCT ID ^ICMJE

NCT00435591

Responsible Party

Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc

Study ID Numbers ^ICMJE

087-CL-084

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP