To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .

Viatris

Status and phase: Completed; Phase 4

Conditions: Impotence; Hypertension

Treatments: Drug: Sildenafil Citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150358

A1481187

Details and patient eligibility

About

To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)