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

Primary Purpose

Impotence, Hypertension

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Sildenafil Citrate
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 6, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00150358
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
253 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
72000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44290
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Colonia Centro
State/Province
Mexico CITY
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Pfizer Investigational Site
City
DF
State/Province
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Aguascalientes
ZIP/Postal Code
C.P. 20230
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Durango
ZIP/Postal Code
34300
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Puebla
ZIP/Postal Code
72090
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis Potosi
ZIP/Postal Code
78090
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis PotosÃ-
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Veracruz
ZIP/Postal Code
C.P. 97897
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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