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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00435591

Purpose

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

Condition	Intervention	Phase
Hyponatremia Euvolemia Hypervolemia	Drug: Conivaptan Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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 or Hypervolemic Hyponatremia

Resource links provided by NLM:

Drug Information available for: YM 087 Conivaptan

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	121
Study Start Date:	January 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental placebo loading dose + ampoule	Drug: Conivaptan ampoule or premix bag Drug: placebo ampoule or premix bag
2: Experimental active loading dose + ampoule	Drug: Conivaptan ampoule or premix bag
3: Experimental placebo loading dose + premix bag	Drug: Conivaptan ampoule or premix bag Drug: placebo ampoule or premix bag
4: Experimental active loading dose + premix bag	Drug: Conivaptan ampoule or premix bag

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435591

Locations

United States, South Carolina

Charleston, South Carolina, United States, 29425
India

Karnal, India, 132001

Bangalore, India, 560034

Bhopal, India, 462001

Hyderabaad, India, 500482

Bangalore, India, 560099
Israel

Safed, Israel, 13100

Holon, Israel, 58100

Zerifin, Israel, 70300

Jerusalem, Israel, 910301

Afula, Israel, 18101

Rechovot, Israel, 76100

Ashkelon, Israel, 78308

Jerusalem, Israel, 91120

Tel Hashomer, Israel, 52621

Tel-Aviv, Israel, 64239

Haifa, Israel, 34362

Haifa, Israel, 31048

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	087-CL-084
Study First Received:	February 14, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00435591 History of Changes
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health; India: Drugs Controller General of India

Keywords provided by Astellas Pharma Inc:

Hyponatremia
Euvolemia
Hypervolemia

Conivaptan
Vaprisol®
YM087

Additional relevant MeSH terms:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 09, 2009