Hypertension, Impotence
Conditions
Brief summary
To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
Interventions
DRUGSildenafil Citrate
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with arterial hypertension treated with one or more antihypertensive agents, the doses of which have been stable for at least 4 weeks prior to the baseline visit, with a documented clinical diagnosis of ED and a confirmation of this by a qualification of 21 or less on the SHI-M.
Exclusion criteria
* Subjects with resting sitting systolic blood pressure \>170 or \<110mmHg or resting sitting diastolic blood pressure \>90 or \<50mmHg, with significant cardiovascular disease and retinitis pigmentosa, treatment with nitrates, alfablockers or CYP3A4 inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy measure is the percent of ITT subjects at week 8 with positive response to the Global Efficacy Assessment question regarding the effectiveness of the medication in improving erections over no treatment at all for ED. | — |
Secondary
| Measure | Time frame |
|---|---|
| The evaluation of change from baseline to week 8 on the toal SHI-M (Sexual Health Inventory-Male) score and the 5 individual items on the SHI-M. Global Efficacy Assessment Questions 2 and 3 at week 8. | — |
Countries
Mexico
Outcome results
None listed