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

NCT ID: NCT00150358

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impotence Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil Citrate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Torreón, Coahuila, Mexico

Site Status

Pfizer Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

Pfizer Investigational Site

Colonia Centro, Mexico City, Mexico

Site Status

Pfizer Investigational Site

DF, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

San Luis PotosÃ-, San Luis PotosÃ-, Mexico

Site Status

Pfizer Investigational Site

Mérida, Yucatán, Mexico

Site Status

Pfizer Investigational Site

Aguascalientes, , Mexico

Site Status

Pfizer Investigational Site

Chihuahua City, , Mexico

Site Status

Pfizer Investigational Site

Durango, , Mexico

Site Status

Pfizer Investigational Site

Metepec, , Mexico

Site Status

Pfizer Investigational Site

Puebla City, , Mexico

Site Status

Pfizer Investigational Site

San Luis Potosí City, , Mexico

Site Status

Pfizer Investigational Site

Veracruz, , Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A1481187

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Quality of Erection Study
NCT00159900 COMPLETED PHASE4
Sildenafil IV Bolus Study
NCT00800592 COMPLETED PHASE1