Clinical trial NCT00150358: To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
Official title: Open Label, Multicenter, Non Comparative Study, To Confirm The Efficacy And Tolerability Of Viagra In Subjects With Erectile Dysfunction And Arterial Hypertension Who Are Taking Antihypertensive Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 253
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Torreon
country: Mexico
facility: Pfizer Investigational Site
state: Coahuila
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Colonia Centro
country: Mexico
facility: Pfizer Investigational Site
state: Mexico CITY
city: DF
country: Mexico
facility: Pfizer Investigational Site
state: Mexico City
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo LEON
city: Merida
country: Mexico
facility: Pfizer Investigational Site
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Durango
country: Mexico
facility: Pfizer Investigational Site
city: Metepec
country: Mexico
facility: Pfizer Investigational Site
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: San Luis PotosÃ-
country: Mexico
facility: Pfizer Investigational Site
city: Veracruz
country: Mexico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: