NCT00450164

Brief Summary

Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
Last Updated

March 21, 2007

Status Verified

March 1, 2007

First QC Date

March 20, 2007

Last Update Submit

March 20, 2007

Conditions

Gastrointestinal HemorrhagePortal HypertensionCirrhosis

Keywords

Variceal bleedingSecondary profilaxisHemodynamicPortal hypertension

Outcome Measures

Primary Outcomes (1)

  • Compared efficacy (at least 6 moths of follow-up)

Secondary Outcomes (2)

  • Mortallity

  • Rebleeding

Interventions

esofagic varices ligationPROCEDURE
NadololDRUG
Isosorbide mononitrateDRUG
PrazosinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
  • Cirrhosis
  • Patient agreement to be included in the study onsentiment signed

You may not qualify if:

  • Any associated comorbidity with life expectancy lesser than 6 months
  • Patient refusement to be included in the study.
  • Pregnancy
  • Failure to control acute bleeding
  • Previous prophylaxis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Sangrantes, HSCSP

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageHypertension, PortalFibrosis

Interventions

Nadololisosorbide-5-mononitratePrazosin

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsLiver Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Candid - Villanueva, Dr.

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

November 1, 2000

Study Completion

June 1, 2004

Last Updated

March 21, 2007

Record last verified: 2007-03

Locations

ES(1)