CirrhosisPhase 3DACAPONCT00493480
Danish Carvedilol Study in Portal Hypertension
A Phase 3 study testing carvedilol and propranolol in people with Cirrhosis and Portal Hypertension, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Portal Hypertension
- What is being tested?
- carvedilol and propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2003to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis
- HVPG > 12 mmHg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
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.
- Conditions
- Cirrhosis, Portal Hypertension
- Being tested
- carvedilol, propranolol
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 25 mg carvedilol daily.
propranololDrug
80 mg of propranolol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubles weekly up to a maximum of 360 mg propranolol daily
| Study group | Role | What they receive |
|---|---|---|
| carvedilol | Active comparator | Not described Receives: Drug: carvedilol |
| propranolol | Active comparator | Cirrhotic patients treated with propranolol Receives: Drug: propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
Measured: 3 months
Secondary outcomes (1)
If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startSep 2003
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Erik F Hansen, MD,Ph.d, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493480
- Sponsor's protocol ID
- KF-02-049/03
- Acronym
- DACAPO
- Status last verified
- Aug 2009
- First submitted
- 27 Jun 2007
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonefeld K, Hobolth L, Juul A, Moller S. The insulin like growth factor system in cirrhosis. Relation to changes in body composition following adrenoreceptor blockade. Growth Horm IGF Res. 2012 Dec;22(6):212-8. doi: 10.1016/j.ghir.2012.09.001. Epub 2012 Sep 30.
PubMed 23031335Hobolth L, Moller S, Gronbaek H, Roelsgaard K, Bendtsen F, Feldager Hansen E. Carvedilol or propranolol in portal hypertension? A randomized comparison. Scand J Gastroenterol. 2012 Apr;47(4):467-74. doi: 10.3109/00365521.2012.666673. Epub 2012 Mar 9.
PubMed 22401315
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
- ClinicalTrials.gov ID
- NCT00493480
- Acronym / sponsor ID
- DACAPO / KF-02-049/03
- Conditions
- Cirrhosis, Portal Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carvedilol | Active comparator | Drug: carvedilol |
| propranolol | Active comparator | Drug: propranololCirrhotic patients treated with propranolol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis
- HVPG > 12 mmHg
Key exclusion criteria (8 listed)
- Respiratory disease that contradict endoscopy
- Hepatic encephalopathy
- Hepatorenal syndrome
- COPD or Asthma
- Treatment with vasoactive drugs within 1 week of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carvedilol6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 25 mg carvedilol daily. | Drug | carvedilol |
| propranolol80 mg of propranolol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubles weekly up to a maximum of 360 mg propranolol daily | Drug | propranolol |
Primary outcome
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
Time frame: 3 months
1 secondary outcome
If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
- Derived from this study: PubMed 23031335Bonefeld K, Hobolth L, Juul A, Moller S. The insulin like growth factor system in cirrhosis. Relation to changes in body composition following adrenoreceptor blockade. Growth Horm IGF Res. 2012 Dec;22(6):212-8. doi: 10.1016/j.ghir.2012.09.001. Epub 2012 Sep 30.
- Derived from this study: PubMed 22401315Hobolth L, Moller S, Gronbaek H, Roelsgaard K, Bendtsen F, Feldager Hansen E. Carvedilol or propranolol in portal hypertension? A randomized comparison. Scand J Gastroenterol. 2012 Apr;47(4):467-74. doi: 10.3109/00365521.2012.666673. Epub 2012 Mar 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik F Hansen, MD,Ph.d principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carvedilol and propranolol in people with Cirrhosis and Portal Hypertension, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493480, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2009.