Hypertension Study: Multinational Torasemide Trial in Mild to Moderate Hypertension.
Launched by FERRER INTERNACIONAL S.A. · Jun 6, 2006
Trial Information
Current as of September 12, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Aged from 18 to 75, inclusive.
- 2. Ambulatory patients diagnosed with mild or moderate arterial hypertension complying with the following requirements:
- • 1. Patients diagnosed "de novo".
- • 2. Patients with prior anti-hypertensive treatment in monotherapy who do not respond to the treatment and, in the investigator's opinion, could benefit from diuretic treatment in monotherapy.
- • 3. Patients with prior anti-hypertensive treatment in monotherapy who do not tolerate the current treatment and, in the investigator's opinion, could benefit from diuretic treatment in monotherapy.
- • 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)
- • 3. Capable of understanding the nature of the trial.
- • 4. Providing their informed consent in writing.
- Exclusion Criteria:
- • 1. Pregnant or breastfeeding women and women of fertile age who are not using a safe contraceptive method or do not intend to use one during the trial. Safe contraceptive methods are oral or parenteral contraceptive treatments or barrier methods: masculine or feminine condom, diaphragm and/or IUD.
- • 2. Severe arterial hypertension (systolic blood pressure of 180 mmHg or above and diastolic blood pressure of 110 mmHg or above).
- • 3. Known or suspected secondary arterial hypertension.
- • 4. History of known hypersensitivity to the compound under study or to sulfonylureas.
- • 5. History of repeated and documented hypertensive crises.
- • 6. NYHA grade II to IV congestive heart failure.
- • 7. Severe cardiac arrhythmia (sustained ventricular tachycardia, auricular fibrillation, auricular flutter, bradycardia under 45 beats per minute).
- • 8. Unstable angina pectoris.
- • 9. Acute myocardial infarct in the last 6 months.
- • 10. Liver failure defined by the following analytical parameters: - SGPT (ALT) or SGOT (AST) over twice the upper normal limit.
- • 11. Chronic kidney failure defined by the following analytical parameters: Serum creatinine over 2.3 mg/dl (or 203 mol/L).
- • 12. Patients with insulin-dependent diabetes and patients with non-insulin dependent diabetes.
- • 13. Cerebrovascular accident in the last 6 months.
- • 14. Contraindications in the data obtained during the selection process in the physical examination, haematology, biochemistry, urine analysis and 12-lead ECG, in the investigator's opinion.
- • 15. Simultaneous participation in another clinical trial or treatment with any investigational drug within the 30 days prior to signing the informed consent form.
- • 16. Lactose intolerance.
- • 17. Concomitant treatment with lithium.
- • 18. Patients requiring chronic treatment (treatment \> 7 days) with non-steroidal anti-inflammatory drugs, including aspirin.
- • 19. Patients with concomitant treatment with aminoglycoside antibiotics, etacrynic acid.
- • 20. Chronic administration of any medication affecting blood pressure.
- • 21. Patients in treatment with group 1a, 1b or 2 anti-arrhythmic drugs.
- • 22. History of drug or alcohol addiction within the 6 months prior to the start of the trial.
- • 23. Any clinical circumstance or condition which, in the investigator's opinion, could affect the possibility of completing the protocol and the administration of Torasemide.
- • 24. Obesity with a body mass index (BMI) of over 40 kg/m2.
- • 25. Patients who do not respond to diuretic treatment in monotherapy.
- • 26. Patients with prior anti-hypertensive treatment in monotherapy who are candidates for anti-hypertensive treatment in polytherapy.
About Ferrer Internacional S.A.
Ferrer Internacional S.A. is a global pharmaceutical and biotechnology company headquartered in Barcelona, Spain, dedicated to improving patient health through the development of innovative therapies and healthcare solutions. With a strong focus on research and development, Ferrer is committed to addressing unmet medical needs across various therapeutic areas, including central nervous system disorders, infectious diseases, and metabolic conditions. The company emphasizes collaboration and strategic partnerships to enhance its clinical trial capabilities, ensuring robust scientific rigor and compliance with regulatory standards. Ferrer's dedication to quality and patient-centric approaches positions it as a key player in the advancement of modern medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Alex Roca, MD, PhD
Study Chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Antonio Coca, MD, PhD
Principal Investigator
H. Clínic Barcelona, Barcelona, Spain
Joaquim Vila, MD
Principal Investigator
Hospital Municipal de Badalona, Badalona, Barcelona, Spain
Javier Sobrino, MD
Principal Investigator
Hospital del Esperit Sant, Santa Coloma de Gramanet, Barcelona, Spain
Jaume Plana, MD
Principal Investigator
Hospital Residencia Sant Camil, Sant Pere de Ribes, Barcelona, Spain
Xavier Farres, MD
Principal Investigator
Centre d'Atenció Primaria El Remei de Vic, Vic, Barcelona, Spain
Joan Garcia, MD, PhD
Principal Investigator
Hospital Universitario La Paz
Manuel Luque, MD
Principal Investigator
Hospital Clínico San Carlos, Madrid, Spain
Luis De Teresa, MD
Principal Investigator
Hospital de Sant Vicenç de Raspeig, Sant Vicenç de Raspeig, Alicante, Spain
Jose Vicente, MD
Principal Investigator
Centro de Salud de Petrel, Petrel, Alicante, Spain
Angela Felip, MD, PhD
Principal Investigator
Hospital de Mataró, Mataró, Barcelona, Spain
Pedro Aranda, MD, PhD
Principal Investigator
Hospital Universitario Carlos Haya, Málaga, Spain
Pablo Gómez, MD, PhD
Principal Investigator
Hospital de Jerez de la Frontera, Cádiz, Spain
Blas Gil, MD
Principal Investigator
Hospital Clínico Universitario San Cecilio, Granada, Spain
Joaquín Aracil, MD
Principal Investigator
Centro de Salud El Cristo, Oviedo, Asturias, Spain
Miguel A Prieto, MD
Principal Investigator
Centro de Salud Vallobin Concinos, Oviedo, Asturias, Spain
Carles Brotons, MD, PhD
Principal Investigator
Centre d'Atenció Primaria Sardenya, Barcelona, Spain
Félix Laporta, MD
Principal Investigator
Centro de Salud La Roda, La Roda, Albacete, Spain
José A División, MD
Principal Investigator
Centro de Salud de Fuentealbilla, Fuentealbilla, Albacete, Spain
Enrique López, MD
Principal Investigator
Centro de Salud de Chinchilla, Chinchilla, Albacete, Spain
Carlos Calvo, MD, PhD
Principal Investigator
Hospital Universitario de Santiago, Santiago de Compostela, Spain
Emili Marco, MD
Principal Investigator
Centre d'Atenció Primaria de Sarrià de Ter, Sarrià de Ter, Girona, Spain
Joan Martorell, MD
Principal Investigator
Centre de Salut de Guisona, Guisona, Lleida, Spain
Montserrat Pujol, MD
Principal Investigator
Centre d'Atenció Primaria El Carmel, Barcelona, Spain
Raquel Adroer, MD
Principal Investigator
Centre d'Atenció Primaria Florida Nord, Barcelona, Spain
Angel Cano, MD
Principal Investigator
Centre d'Atenció Primaria Bon Pastor, Barcelona, Spain
Nadezhda S Alexeeva, PhD
Principal Investigator
St. Petersburg Cardiology Clinic, St. Petesburg, Russia
Andrei Y Baranovsky, MD, PhD
Principal Investigator
St. Petersburg City Hospital #31, St. Petesburg, Russia
Svetlana A Boldueva, MD, PhD
Principal Investigator
St. Petersburg Mechnikov State Medical Academy, St. Petesburg, Russia
Svetlana K Churina, MD, PhD
Principal Investigator
Pokrovskaya Hospital, 1-st and 2-nd Cardiology Department, St. Petesburg, Russia
Boris M Goloschekin, MD, PhD
Principal Investigator
St. Petersburg City Hospital #15, St. Petesburg, Russia
Yanis Y Dumpis, MD
Principal Investigator
St.Petersburg Mechnikov State Medical Academy North-West Center of Arrhythmia Diagnostics and Treatment, St. Petesburg, Russia
Konstantin N Zrazhevsky, MD, PhD
Principal Investigator
St.Petersburg City Hospital #8, St. Petesburg, Russia
Victor Kostenko, MD, PhD
Principal Investigator
St.Petersburg City Outpatient Unit #109, St. Petesburg, Russia
Elena F Pavlysh, MD, PhD
Principal Investigator
St.Petersburg City Outpatient Unit #25, St. Petesburg, Russia
Lev A Sorokin, MD, PhD
Principal Investigator
St. Elizabeth City Hospital, St. Petesburg, Russia
Irina A Zobenko, MD
Principal Investigator
JSC Chernaya Rechka Health Center, St. Petesburg, Russia
Alexander O Sherenkov, MD, PhD
Principal Investigator
Krasnogvardeysky District Medical-Physiology Clinic, St. Petesburg, Russia
Alexander V Orlov-Morozov, MD, PhD
Principal Investigator
Moscow City Hospital #23, Moscow, Russia
Vladimir A Parfenov, MD, PhD
Principal Investigator
Moscow City Hospital #61, Moscow, Russia
Victor A Milyagin, MD, PhD
Principal Investigator
Smolensk State Medical Academy, Smolensk, Russia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials