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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150358
First received: September 6, 2005
Last updated: December 7, 2006
Last verified: December 2006
  Purpose

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


Condition Intervention Phase
Impotence
Hypertension
Drug: Sildenafil Citrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Estimated Enrollment: 253
Study Start Date: March 2005
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150358

Locations
Mexico
Pfizer Investigational Site
Torreon, Coahuila, Mexico, 72000
Pfizer Investigational Site
Mexico, DF, Mexico, 07760
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44290
Pfizer Investigational Site
Colonia Centro, Mexico City, Mexico, 06090
Pfizer Investigational Site
DF, Mexico City, Mexico, 06760
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64460
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64000
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97070
Pfizer Investigational Site
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 Potosí, Mexico, 78240
Pfizer Investigational Site
Veracruz, Mexico, C.P. 97897
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150358     History of Changes
Other Study ID Numbers: A1481187
Study First Received: September 6, 2005
Last Updated: December 7, 2006
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014