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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2004-000876-14 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Torasemide Prolonged Release (loop diuretic) | Drug | |||
| Torasemide Immediate Release (loop diuretic) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mm Hg between the mean diastolic blood pressure (DBP) values the baseline period and the values at the end of the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mm Hg, systolic blood pressure (SBP) values in the baseline period and the values at the end of the treatment period. | ||
| Percentage of patients with controlled blood pressure (SBP < 140 and/or DBP < 90) at the end of the treatment period. |
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Inclusion Criteria:
Aged from 18 to 75, inclusive.
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)
Capable of understanding the nature of the trial.
Providing their informed consent in writing.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Roca, MD, PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |
| 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 | 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 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D049994 | Sodium Potassium Chloride Symporter Inhibitors |
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Urinary symptoms. |
| ABPM values measured in a subgroup of patients |
| Safety & tolerability. |
| 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 | Principal Investigator |
| D004232 | Diuretics |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |