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
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|ClinicalTrials.gov Identifier: NCT01549158|
Recruitment Status : Terminated (Slow recruitment)
First Posted : March 9, 2012
Last Update Posted : April 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Compensated Heart Failure||Drug: torasemide-PR Drug: Furosemide-IR Drug: torasemide-IR||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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).|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
|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
- The efficiency of sodium excretion [ Time Frame: 24 hours ]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 ]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.
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): NCT01549158
|Centre d'Investigació de Medicaments (CIM), Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|