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| Sponsor: | Ferrer Internacional S.A. |
|---|---|
| Collaborator: |
None |
| Information provided by: | Ferrer Internacional S.A. |
| ClinicalTrials.gov Identifier: | NCT00334386 |
Purpose
Primary objective:To demonstrate the no-inferiority in efficacy of treatment with Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.
Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Torasemide Prolonged Release (loop diuretic) Drug: Torasemide Immediate Release (loop diuretic) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Multicentre, Multinational, Parallel, Randomised, Double Blind Clinical Trial, to Evaluate the Non-Inferiority of PR Torasemide Versus IR Torasemide in Patients With Mild or Moderate Arterial Hypertension. |
| Estimated Enrollment: | 388 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | February 2006 |
Torsemide is a loop diuretic from the group of pyridine-sulfonylureas, which acts on the ascending large portion of the Henle loop where it inhibits the Na+/K+/2Cl- transport!system and blocks Cl- channels.Therefore, sodium and chlorine ions and water can not be reabsorbed in the tubule and the urine volume increases significantly. Torsemide is used for the treatment of oedema associated with congestive heart failure, kidney or liver disease and, either alone or combined with other anti-hypertensive drugs, for the treatment of arterial hypertension.
This trial compares the effect of a new formulation of Torasemide (Torasemide prolonged release)to the already available immediate release formulation of the same drug on the treatment of mild to moderate hypertensive patients.
Eligible patients will be randomised to either treatment with Torasemide prolonged release or with Torasemide immediate release and will be followed-up until completing 3 months of treatment.Blood pressure will be measured by an OMRON pressure gauge. Additionally, ABPM will be performed on a sub-group of the patients taking part in this trial.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ambulatory patients diagnosed with mild or moderate arterial hypertension complying with the following requirements:
Patients with prior treatment must be able to interrupt their present treatment for a period of up to 3 months.
(Mild or moderate hypertension defined by blood pressure levels: Systolic blood pressure from 140-179 mm Hg and diastolic blood pressure from 90-109 mm Hg) (2003 European Society of Hypertension-European Society of Cardiology guidelines for management of arterial hypertension) (3)
Exclusion Criteria:
Contacts and Locations| Study Chair: | Alex Roca, MD, PhD | Hospital de la Santa Creu i Sant Pau, Barcelona (Spain) |
| Principal Investigator: | Antonio Coca, MD, PhD | H. Clínic Barcelona, Barcelona, Spain |
| Principal Investigator: | Joaquim Vila, MD | Hospital Municipal de Badalona, Badalona, Barcelona, Spain |
| Principal Investigator: | Javier Sobrino, MD | Hospital del Esperit Sant, Santa Coloma de Gramanet, Barcelona, Spain |
| Principal Investigator: | Jaume Plana, MD | Hospital Residencia Sant Camil, Sant Pere de Ribes, Barcelona, Spain |
| Principal Investigator: | Xavier Farres, MD | Centre d'Atenció Primaria El Remei de Vic, Vic, Barcelona, Spain |
| Principal Investigator: | Joan Garcia, MD, PhD | Hospital Universitario La Paz, Madrid, Spain |
| Principal Investigator: | Manuel Luque, MD | Hospital Clínico San Carlos, Madrid, Spain |
| Principal Investigator: | Luis De Teresa, MD | Hospital de Sant Vicenç de Raspeig, Sant Vicenç de Raspeig, Alicante, Spain |
| Principal Investigator: | Jose Vicente, MD | Centro de Salud de Petrel, Petrel, Alicante, Spain |
| Principal Investigator: | Angela Felip, MD, PhD | Hospital de Mataró, Mataró, Barcelona, Spain |
| Principal Investigator: | Pedro Aranda, MD, PhD | Hospital Universitario Carlos Haya, Málaga, Spain |
| Principal Investigator: | Pablo Gómez, MD, PhD | Hospital de Jerez de la Frontera, Cádiz, Spain |
| Principal Investigator: | Blas Gil, MD | Hospital Clínico Universitario San Cecilio, Granada, Spain |
| Principal Investigator: | Joaquín Aracil, MD | Centro de Salud El Cristo, Oviedo, Asturias, Spain |
| Principal Investigator: | Miguel A Prieto, MD | Centro de Salud Vallobin Concinos, Oviedo, Asturias, Spain |
| Principal Investigator: | Carles Brotons, MD, PhD | Centre d'Atenció Primaria Sardenya, Barcelona, Spain |
| Principal Investigator: | Félix Laporta, MD | Centro de Salud La Roda, La Roda, Albacete, Spain |
| Principal Investigator: | José A División, MD | Centro de Salud de Fuentealbilla, Fuentealbilla, Albacete, Spain |
| Principal Investigator: | Enrique López, MD | Centro de Salud de Chinchilla, Chinchilla, Albacete, Spain |
| Principal Investigator: | Carlos Calvo, MD, PhD | Hospital Universitario de Santiago, Santiago de Compostela, Spain |
| Principal Investigator: | Emili Marco, MD | Centre d'Atenció Primaria de Sarrià de Ter, Sarrià de Ter, Girona, Spain |
| Principal Investigator: | Joan Martorell, MD | Centre de Salut de Guisona, Guisona, Lleida, Spain |
| Principal Investigator: | Montserrat Pujol, MD | Centre d'Atenció Primaria El Carmel, Barcelona, Spain |
| Principal Investigator: | Raquel Adroer, MD | Centre d'Atenció Primaria Florida Nord, Barcelona, Spain |
| Principal Investigator: | Angel Cano, MD | Centre d'Atenció Primaria Bon Pastor, Barcelona, Spain |
| Principal Investigator: | Nadezhda S Alexeeva, PhD | St. Petersburg Cardiology Clinic, St. Petesburg, Russia |
| Principal Investigator: | Andrei Y Baranovsky, MD, PhD | St. Petersburg City Hospital #31, St. Petesburg, Russia |
| Principal Investigator: | Svetlana A Boldueva, MD, PhD | St. Petersburg Mechnikov State Medical Academy, St. Petesburg, Russia |
| Principal Investigator: | Svetlana K Churina, MD, PhD | Pokrovskaya Hospital, 1-st and 2-nd Cardiology Department, St. Petesburg, Russia |
| Principal Investigator: | Boris M Goloschekin, MD, PhD | St. Petersburg City Hospital #15, St. Petesburg, Russia |
| Principal Investigator: | Yanis Y Dumpis, MD | St.Petersburg Mechnikov State Medical Academy North-West Center of Arrhythmia Diagnostics and Treatment, St. Petesburg, Russia |
| Principal Investigator: | Konstantin N Zrazhevsky, MD, PhD | St.Petersburg City Hospital #8, St. Petesburg, Russia |
| Principal Investigator: | Victor Kostenko, MD, PhD | St.Petersburg City Outpatient Unit #109, St. Petesburg, Russia |
| Principal Investigator: | Elena F Pavlysh, MD, PhD | St.Petersburg City Outpatient Unit #25, St. Petesburg, Russia |
| Principal Investigator: | Lev A Sorokin, MD, PhD | St. Elizabeth City Hospital, St. Petesburg, Russia |
| Principal Investigator: | Irina A Zobenko, MD | JSC Chernaya Rechka Health Center, St. Petesburg, Russia |
| Principal Investigator: | Alexander O Sherenkov, MD, PhD | Krasnogvardeysky District Medical-Physiology Clinic, St. Petesburg, Russia |
| Principal Investigator: | Alexander V Orlov-Morozov, MD, PhD | Moscow City Hospital #23, Moscow, Russia |
| Principal Investigator: | Vladimir A Parfenov, MD, PhD | Moscow City Hospital #61, Moscow, Russia |
| Principal Investigator: | Victor A Milyagin, MD, PhD | Smolensk State Medical Academy, Smolensk, Russia |
More Information
| Study ID Numbers: | P030089-01, EudraCT: 2004-000876-14 |
| Study First Received: | June 6, 2006 |
| Last Updated: | June 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00334386 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines; Russia: Pharmacological Committee, Ministry of Health |
|
Hypertension Anti-hypertensive effect Diuretic |
|
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Vascular Diseases Torsemide Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Sodium Potassium Chloride Symporter Inhibitors Hypertension |