NCT00115947

Brief Summary

The purpose of this study is to investigate the effect of terlipressin on myocardial perfusion and renal function. Hypothesis: Significant improvement of renal function reflected by: glomerular filtration rate (GFR), renal blood flow (RBF), excretion of salt and metabolites in the urine and related hormones and peptides in the blood. No effect on the systolic function of the heart.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 9, 2006

Status Verified

June 1, 2005

First QC Date

June 26, 2005

Last Update Submit

March 8, 2006

Conditions

CirrhosisAscites

Interventions

TerlipressinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis and ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

FibrosisAscites

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Aleksander Krag Krag, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

December 1, 2004

Study Completion

January 1, 2006

Last Updated

March 9, 2006

Record last verified: 2005-06

Locations

DK(1)