Status:
COMPLETED
Hypertension Study: Multinational Torasemide Trial in Mild to Moderate Hypertension.
Lead Sponsor:
Ferrer Internacional S.A.
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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...
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- cha...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Lactose intolerance.
- Concomitant treatment with lithium.
- Patients requiring chronic treatment (treatment \> 7 days) with non-steroidal anti-inflammatory drugs, including aspirin.
- Patients with concomitant treatment with aminoglycoside antibiotics, etacrynic acid.
- Chronic administration of any medication affecting blood pressure.
- Patients in treatment with group 1a, 1b or 2 anti-arrhythmic drugs.
- History of drug or alcohol addiction within the 6 months prior to the start of the trial.
- Any clinical circumstance or condition which, in the investigator's opinion, could affect the possibility of completing the protocol and the administration of Torasemide.
- Obesity with a body mass index (BMI) of over 40 kg/m2.
- Patients who do not respond to diuretic treatment in monotherapy.
- Patients with prior anti-hypertensive treatment in monotherapy who are candidates for anti-hypertensive treatment in polytherapy.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT00334386
Start Date
April 1 2005
End Date
February 1 2006
Last Update
March 6 2015
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