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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00150358
• Date of registration: 06/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
• Scientific 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.
• Date of first enrolment: March 2005
• Target sample size: 253
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00150358
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Hypertension

Impotence

Intervention(s)

Drug: Sildenafil Citrate

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

A1481187

Source(s) of Monetary Support

Please refer to primary and secondary sponsors