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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00150358
• Collaborator: (none)
• Enrollment: 253
• Locations: 16
• Duration (Months): 8
• Patients Per Site: 15.8
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Impotence; Hypertension	Drug: Sildenafil Citrate	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Mar 1, 2005
• Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Torreon	Coahuila	Mexico	72000
2	Pfizer Investigational Site	Mexico	DF	Mexico	07760
3	Pfizer Investigational Site	Guadalajara	Jalisco	Mexico	44290
4	Pfizer Investigational Site	Colonia Centro	Mexico CITY	Mexico	06090
5	Pfizer Investigational Site	DF	Mexico City	Mexico	06760
6	Pfizer Investigational Site	Monterrey	Nuevo Leon	Mexico	64000
7	Pfizer Investigational Site	Monterrey	Nuevo LEON	Mexico	64460
8	Pfizer Investigational Site	Merida	Yucatan	Mexico	97070
9	Pfizer Investigational Site	Aguascalientes		Mexico	C.P. 20230
10	Pfizer Investigational Site	Chihuahua		Mexico	31238
11	Pfizer Investigational Site	Durango		Mexico	34300
12	Pfizer Investigational Site	Metepec		Mexico	52140
13	Pfizer Investigational Site	Puebla		Mexico	72090
14	Pfizer Investigational Site	San Luis Potosi		Mexico	78090
15	Pfizer Investigational Site	San Luis PotosÃ-		Mexico	78240
16	Pfizer Investigational Site	Veracruz		Mexico	C.P. 97897

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00150358
• Other Study ID Numbers: A1481187
• First Posted: Sep 8, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Erectile Dysfunction; Hypertension; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021