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Hypertension Study: Multinational Torasemide Trial in Mild to Moderate Hypertension.

This study has been completed.

Sponsors and Collaborators: Ferrer Internacional S.A.
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

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Torsemide   

U.S. FDA Resources

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.

Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.
  • Urinary symptoms.
  • ABPM values measured in a subgroup of patients
  • Safety & tolerability.

Estimated Enrollment:   388
Study Start Date:   April 2005
Estimated Study Completion Date:   February 2006

Detailed Description:

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

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334386

Sponsors and Collaborators
Ferrer Internacional S.A.
None

Investigators
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
First Received:   June 6, 2006
Last Updated:   June 6, 2006
ClinicalTrials.gov Identifier:   NCT00334386
Health Authority:   Spain: Spanish Agency of Medicines;   Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Ferrer Internacional S.A.:
Hypertension  
Anti-hypertensive effect  
Diuretic  

Study placed in the following topic categories:
Vascular Diseases
Torsemide
Hypertension

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008




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