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

NCT00334386 | Completed Phase 4

• 2 other identifiers: P030089-01EudraCT: 2004-000876-14
• Study Type: interventional
• Target: 388
• Locations: 0 countries
• Sites: N/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.

Conditions

Hypertension

Keywords

Hypertension; Anti-hypertensive effect; Diuretic

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• 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.

Interventions

Torasemide Prolonged Release (loop diuretic) DRUG

Torasemide Immediate Release (loop diuretic) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 75, inclusive.
• Ambulatory patients diagnosed with mild or moderate arterial hypertension complying with the following requirements:
• Patients diagnosed "de novo".
• 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.
• 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)
• Capable of understanding the nature of the trial.
• Providing their informed consent in writing.

You may not qualify if:

• 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.
• Severe arterial hypertension (systolic blood pressure of 180 mmHg or above and diastolic blood pressure of 110 mmHg or above).
• Known or suspected secondary arterial hypertension.
• History of known hypersensitivity to the compound under study or to sulfonylureas.
• History of repeated and documented hypertensive crises.
• NYHA grade II to IV congestive heart failure.
• Severe cardiac arrhythmia (sustained ventricular tachycardia, auricular fibrillation, auricular flutter, bradycardia under 45 beats per minute).
• Unstable angina pectoris.
• Acute myocardial infarct in the last 6 months.
• Liver failure defined by the following analytical parameters: - SGPT (ALT) or SGOT (AST) over twice the upper normal limit.
• Chronic kidney failure defined by the following analytical parameters: Serum creatinine over 2.3 mg/dl (or 203 mol/L).
• Patients with insulin-dependent diabetes and patients with non-insulin dependent diabetes.
• Cerebrovascular accident in the last 6 months.
• 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.
• Simultaneous participation in another clinical trial or treatment with any investigational drug within the 30 days prior to signing the informed consent form.

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

MeSH Terms

Conditions

Hypertension

Interventions

Sodium Potassium Chloride Symporter Inhibitors; Torsemide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: April 1, 2005
• Study Completion: February 1, 2006
• Last Updated: March 6, 2015

Record last verified: 2015-03