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

NCT00150358 | Completed Phase 4

• 1 other identifier: A1481187
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Impotence; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

Sildenafil Citrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (16)

Pfizer Investigational Site

Torreón, Coahuila, 72000, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44290, Mexico

Location

Pfizer Investigational Site

Colonia Centro, Mexico City, 06090, Mexico

Location

Pfizer Investigational Site

DF, Mexico City, 06760, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 07760, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64000, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

San Luis PotosÃ-, San Luis PotosÃ-, 78240, Mexico

Location

Pfizer Investigational Site

Mérida, Yucatán, 97070, Mexico

Location

Pfizer Investigational Site

Aguascalientes, C.P. 20230, Mexico

Location

Pfizer Investigational Site

Chihuahua City, 31238, Mexico

Location

Pfizer Investigational Site

Durango, 34300, Mexico

Location

Pfizer Investigational Site

Metepec, 52140, Mexico

Location

Pfizer Investigational Site

Puebla City, 72090, Mexico

Location

Pfizer Investigational Site

San Luis Potosí City, 78090, Mexico

Location

Pfizer Investigational Site

Veracruz, C.P. 97897, Mexico

Location

MeSH Terms

Conditions

Erectile Dysfunction; Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

ME (16)