NCT00334386

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 388 (planned)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Torasemide Prolonged Release (loop diuretic)
DRUG	Torasemide Immediate Release (loop diuretic)

Timeline

• Start date: 2005-04-01
• Completion: 2006-02-01
• First posted: 2006-06-07
• Last updated: 2015-03-06