NCT01103154 (Carvedilol) is a Phase 4 clinical trial of carvedilol in Variceal Rebleeding, sponsored by E-DA Hospital.

Who is sponsoring NCT01103154?

NCT01103154 is sponsored by E-DA Hospital.

What drugs are being tested in NCT01103154?

Interventions in NCT01103154: carvedilol, nadolol + ISMN.

What condition does NCT01103154 study?

NCT01103154 studies Variceal Rebleeding.

Is NCT01103154 still recruiting?

NCT01103154 is currently completed. Last updated 24 October 2010.

Last reviewed 2010-10-24 · How we verify

NCT01103154: Carvedilol

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Controlled Trial of Nadolol Plus Isosorbide Mononitrate vs. Carvedilol for the Prevention of Variceal Rebleeding

Completed Phase 4 Last updated 24 October 2010

What this trial tests

Phase 4 trial testing carvedilol in Variceal Rebleeding in 121 participants. Completed in 1 January 2010.

Timeline

1 March 2005

Primary endpoint
1 January 2010

1 January 2010

Quick facts

Lead sponsor	E-DA Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	121
Start date	1 March 2005
Primary completion	1 January 2010
Estimated completion	1 January 2010

Drugs / interventions tested

carvedilol (CARVEDILOL) — full drug profile →
nadolol + ISMN — full drug profile →

Conditions studied

Variceal Rebleeding — all drugs for Variceal Rebleeding →

Sponsor

E-DA Hospital

Who can join

Adults 20 to 75, any sex, with Variceal Rebleeding. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

variceal rebleeding
Time frame: 2 years
hematemesis or melena,requiring blood transfusion of 2 units or more bleeding source was proven endoscopically to be from esophageal varices

Sponsor's own description

Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Secondary prevention of variceal bleeding in adults with previous oesophageal variceal bleeding due to decompensated liver cirrhosis: a network meta-analysis.
Plaz Torres MC, Best LM, Freeman SC, Roberts D, et al · · 2021 · cited 19× · PMID 33784794 · DOI 10.1002/14651858.cd013122.pub2
Treatment for bleeding oesophageal varices in people with decompensated liver cirrhosis: a network meta-analysis.
Roberts D, Best LM, Freeman SC, Sutton AJ, et al · · 2021 · cited 16× · PMID 33837526 · DOI 10.1002/14651858.cd013155.pub2

Verify or expand the search:

Other trials of carvedilol

Trials testing the same drug.

NCT01383044 — Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding · Phase 4 · terminated
NCT01212250 — Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis · NA · recruiting
NCT01059396 — Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal · Phase 4 · completed

Other E-DA Hospital trials

Trials by the same sponsor.

NCT03848260 — A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos · NA · suspended
NCT06482411 — Risk Factors Affect Weight Loss Outcomes After Treatment. · completed
NCT05863208 — Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision · NA · recruiting
NCT06460402 — Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care · NA · enrolling by invitation
NCT06420388 — 2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01103154 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by E-DA Hospital
Last refreshed: 24 October 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01103154.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing