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

• ClinicalTrials.gov Identifier: NCT00150358
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Last Update Posted: December 11, 2006
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: September 6, 2005
• First Posted Date: September 8, 2005
• Last Update Posted Date: December 11, 2006
• Study Start Date: March 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 6, 2005): 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.
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00150358 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: September 6, 2005): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
• 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.
• Brief Summary: To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Impotence
• Hypertension

• Intervention: Drug: Sildenafil Citrate
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 6, 2005): 253
• Original Enrollment: Same as current
• Study Completion Date: November 2005
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT00150358
• Other Study ID Numbers: A1481187
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2006