Single Dose Study to Compare the Pharmacodynamics of Torasemide-PR 10 mg,Torasemide-IR 10 mg and Furosemide-IR 40 mg in Patients With Compensated Heart Failure
This is a randomized, open-label, blinded-endpoint, crossover, single dose study to compare the pharmacodynamics of Torasemide-PR 10 mg, Torasemide-IR10 mg and furosemide-IR 40 mg. 30 patients of both sexes with CHF with a maximum imbalance of 60:40% in either direction will be included in the study. Patients with compensated heart failure, grade II or III as defined by the European Society of Cardiology, with a duration of ≥ 3 months at the time of inclusion documented in the patient's record or patients who previously required diuretic therapy.
Principal variable will be the efficiency of sodium excretion that will be assessed as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours.
The difference between the efficiency of 24 hour sodium excretion following administration of torasemide PR and furosemide will be formally tested by means of a Students t-test for paired samples. The test will be two-sided at 5% significance level. Efficiency changes over time will also be assessed, however will not be subject to formal statistical testing.
Compensated Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized, Open-Label, Blinded-Endpoint, Crossover, Single Dose Study to Compare the Pharmacodynamics of Torasemide-PR 10 mg,Torasemide-IR 10 mg and Furosemide-IR 40 mg, in Patients With Compensated Heart Failure (CHF).|
- The efficiency of sodium excretion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Will be assessed as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours.
- Pharmacokinetic plasma parameters and pharmacokinetic urine parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Pharmacokinetic plasma parameters (Cmax, AUC0-t, AUC0-∞, t ½, Vd / F, Cl / F), pharmacokinetic urine parameters (ERFco , Ae24h, Ae ∞) and urine pharmacodynamic variables will be presented descriptively with no formal statistical testing.
|Study Start Date:||February 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: Torasemide PR 10 mg||
Single oral dose of torasemide PR 10 mg
|Active Comparator: Furosemide-IR 40 mg||
Single oral dose of furosemide IR 40 mg
|Active Comparator: Torasemide-IR 10 mg||
Single oral dose of torasemide IR 10 mg
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549158
|Centre d'Investigació de Medicaments (CIM), Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|