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

NCT00150358

Last updated date
Study Location
Pfizer Investigational Site
Torreon, Coahuila, 72000, Mexico
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impotence, Hypertension
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Impotence, HypertensionTo Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
NCT00150358
  1. Torreon, Coahuila
  2. Mexico, DF
  3. Guadalajara, Jalisco
  4. Colonia Centro, Mexico City
  5. DF, Mexico City
  6. Monterrey, Nuevo Leon
  7. Monterrey, Nuevo Leon
  8. Merida, Yucatan
  9. Aguascalientes,
  10. Chihuahua,
  11. Durango,
  12. Metepec,
  13. Puebla,
  14. San Luis Potosi,
  15. San Luis PotosÃ-,
  16. Veracruz,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
Official Title  ICMJE 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.
Brief Summary To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Impotence
  • Hypertension
Intervention  ICMJE Drug: Sildenafil Citrate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 6, 2005)
253
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150358
Other Study ID Numbers  ICMJE A1481187
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP