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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

253

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Aguascalientes, Mexico, C.P. 20230
        • Pfizer Investigational Site
      • Chihuahua, Mexico, 31238
        • Pfizer Investigational Site
      • Durango, Mexico, 34300
        • Pfizer Investigational Site
      • Metepec, Mexico, 52140
        • Pfizer Investigational Site
      • Puebla, Mexico, 72090
        • Pfizer Investigational Site
      • San Luis Potosi, Mexico, 78090
        • Pfizer Investigational Site
      • San Luis PotosÃ-, Mexico, 78240
        • Pfizer Investigational Site
      • Veracruz, Mexico, C.P. 97897
        • Pfizer Investigational Site
    • Coahuila
      • Torreon, Coahuila, Mexico, 72000
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 07760
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44290
        • Pfizer Investigational Site
    • Mexico CITY
      • Colonia Centro, Mexico CITY, Mexico, 06090
        • Pfizer Investigational Site
    • Mexico City
      • DF, Mexico City, Mexico, 06760
        • Pfizer Investigational Site
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Pfizer Investigational Site
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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