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NCT00563602
Randomized and Controlled Study of Endoscopic Ligation, Nadolol and Isosorbide Mononitrate vs Endoscopic Ligation and Nadolol Alone, or Associated With Isosorbide Mononitrate or Prazosin, Depending of the Hemodinamyc Response
Phase 4 trial testing Hemodynamic guided therapy in Portal Hypertension in 140 participants. Status unknown.
Quick facts
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 140 |
| Start date | 1 August 2007 |
| Estimated completion | 1 November 2007 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Hemodynamic guided therapy
Conditions studied
- Portal Hypertension — all drugs for Portal Hypertension →
- Complications of Cirrhosis — all drugs for Complications of Cirrhosis →
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Who can join
Adults 18 to 80, any sex, with Portal Hypertension or Complications of Cirrhosis. 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.
-
Rebleeding
Time frame: 1-2 Years
Sponsor's own description
This is a prospective trial of random distribution, open, parallel group, in which patients with esophagic variceal bleeding will be randomized into two treatment groups, after controlling acute bleeding. All patients received standard medical therapy with b-blockers and endoscopic ligation (LEV) of esophageal varices. The control group will be assigned to receive LEV + Nadolol + MNI. The experimental group will be assigned to receive treatment according to the hemodynamic response. All patients included in the experimental group received LEV and pharmacological treatment nadolol alone or combined with MNI or Prazosin (PZ)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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:
- PubMed search for NCT00563602
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Portal Hypertension
Currently open trials in the same condition.
- NCT07439939 — Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Place · recruiting
- NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
- NCT07419724 — Construction of a Portal Hypertension Biobank · recruiting
- NCT07116096 — Effect of Handgrip Strength on Portal Vein Hemodynamics in Patients With Liver Cirrhosis · NA · recruiting
- NCT07080697 — A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hyper · NA · recruiting
Other Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials
Trials by the same sponsor.
- NCT07343882 — Quantification of Systemic Congestion by Ultrasound As a Predictor of Weaning Failure From Mechanical Ventilation · NA · not yet recruiting
- NCT07530237 — Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusio · active not recruiting
- NCT07369310 — Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming · NA · not yet recruiting
- NCT07314190 — Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodege · enrolling by invitation
- NCT07239843 — Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychia · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00563602 (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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Last refreshed: 22 November 2007
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/NCT00563602.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing