Not Signed In -
Erectile Dysfunction |
ED; Erectile Disorder; Erectile Disorder (Impotence) |
Clinical Trial: To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
This study is no longer recruiting patients.
|
Purpose
To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Erectile Dysfunction Hypertension | Drug: Sildenafil Citrate | Phase IV |
MedlinePlus related topics: Erectile Dysfunction; High Blood Pressure
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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.
Further Study Details:
Primary Outcomes: 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: 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.
Expected Total Enrollment: 253
Secondary Outcomes: 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.
Expected Total Enrollment: 253
Study start: March 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
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.
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1481187
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150358
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150358
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
ClinicalTrials.gov processed this record on 2005-09-13
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