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A Single-blind, Multiple Dose, Placebo-controlled, Double Dummy Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure
This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 37 |
| Start date | 2010-05 |
| Completion | 2011-08 |
Conditions
- Heart Failure
Interventions
- Aliskiren 150 mg
- Furosemide 60 mg
- Placebo for Aliskiren
- Aliskiren 300 mg
Primary outcomes
- Diuretic Efficacy Index 1 for Sodium Excretion — 0 to 4 hours
Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection. - Diuretic Efficacy Index 1 for Sodium Excretion — 0 to 24 hours
Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection. - Diuretic Efficacy Index 2 for Water Excretion — 0 to 4 hours
Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection. - Diuretic Efficacy Index 2 for Water Excretion — 0 to 24 hours
Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.
Countries
Germany, Lithuania