drugset / Trial / NCT01364701

Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment

NCT01364701

Phase 4 Unknown 30 enrolled Rambam Health Care Campus
RandomizedParallel-groupTriple-blindTreatment

Summary

Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus single maximal dose PDE5i therapy.

Timeline

Start
2011-06
Primary completion
2012-06
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sildenafil Unknown 50 mg
Comparator Sildenafil Unknown 100 mg
Comparator Tadalafil Small molecule 10 mg
Comparator Tadalafil Small molecule 20 mg

Indications