drugset / Trial / NCT01364701
Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sildenafil | Unknown | 50 mg | — |
| Comparator | Sildenafil | Unknown | 100 mg | — |
| Comparator | Tadalafil | Small molecule | 10 mg | — |
| Comparator | Tadalafil | Small molecule | 20 mg | — |