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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150358
• Other study ID #: A1481187
• Status: Completed
• Phase: Phase 4
• Start date: March 2005
• Est. completion date: November 2005

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypertension
• Impotence

Intervention

Drug:
• Sildenafil Citrate

Locations

Country	Name	City	State
Mexico	Pfizer Investigational Site	Aguascalientes
Mexico	Pfizer Investigational Site	Chihuahua
Mexico	Pfizer Investigational Site	Colonia Centro	Mexico CITY
Mexico	Pfizer Investigational Site	DF	Mexico City
Mexico	Pfizer Investigational Site	Durango
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Merida	Yucatan
Mexico	Pfizer Investigational Site	Metepec
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Mexico	Pfizer Investigational Site	Monterrey	Nuevo LEON
Mexico	Pfizer Investigational Site	Puebla
Mexico	Pfizer Investigational Site	San Luis PotosÃ-
Mexico	Pfizer Investigational Site	San Luis Potosi
Mexico	Pfizer Investigational Site	Torreon	Coahuila
Mexico	Pfizer Investigational Site	Veracruz

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.