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

Phase 4CompletedNCT00150358

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.253 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

253

Conditions

Impotence Hypertension

Interventions

Sildenafil CitrateDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Pfizer Investigational Site

Torreón, Coahuila, Mexico

Pfizer Investigational Site

Guadalajara, Jalisco, Mexico

Pfizer Investigational Site

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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