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

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ClinicalTrials.gov Identifier: NCT00334386
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : March 6, 2015
Sponsor:
Information provided by:
Ferrer Internacional S.A.

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: Torasemide Prolonged Release (loop diuretic) Drug: Torasemide Immediate Release (loop diuretic) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : April 2005
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Torsemide




Primary Outcome Measures :
  1. 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 :
  1. Difference in mm Hg, systolic blood pressure (SBP) values in the baseline period and the values at the end of the treatment period.
  2. Percentage of patients with controlled blood pressure (SBP < 140 and/or DBP < 90) at the end of the treatment period.
  3. Urinary symptoms.
  4. ABPM values measured in a subgroup of patients
  5. Safety & tolerability.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334386


Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
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Study Chair: Alex Roca, MD, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
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

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ClinicalTrials.gov Identifier: NCT00334386     History of Changes
Other Study ID Numbers: P030089-01
EudraCT: 2004-000876-14
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Diuretics
Torsemide
Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents