Danish Carvedilol Study in Portal Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

June 27, 2007

Last Updated Date

August 7, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

If Carvedilol has better efficacy on lowering the portal pressure than propranolol in patients with cirrhosis

Change History

Complete list of historical versions of study NCT00493480 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Danish Carvedilol Study in Portal Hypertension

Official Title ^ICMJE

Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices

Brief Summary

Patients with large esophageal varices who have not yet experienced bleeding, are normally treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or have to discontinue the treatment because of side effects. The aim of this study is to evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than propranolol in lowering the portal pressure in patients with cirrhosis.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cirrhosis
Portal Hypertension

Intervention ^ICMJE

Drug: carvedilol
Drug: propranolol

Study Arms / Comparison Groups

Active Comparator: Cirrhotic patients treated with propranolol

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

Estimated Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cirrhosis
HVPG > 12 mmHg

Exclusion Criteria:

Respiratory disease that contradict endoscopy
Hepatic encephalopathy
Hepatorenal syndrome
COPD or Asthma
Treatment with vasoactive drugs within 1 week of inclusion
Heart disease that contradict treatment with beta-blocking agents
IDDM
Pregnancy

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00493480

Responsible Party

Erik Feldager/ sponsor, Erik Feldager, Hvidovre Hospital

Study ID Numbers ^ICMJE

KF-02-049/03

Study Sponsor ^ICMJE

Hvidovre University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Erik F Hansen, MD,Ph.d

Unaffiliated

Information Provided By

Hvidovre University Hospital

Verification Date

August 2009

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