To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150358
First received: September 6, 2005
Last updated: December 7, 2006
Last verified: December 2006
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Purpose
To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Impotence Hypertension |
Drug: Sildenafil Citrate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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:
- 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.
| Estimated Enrollment: | 253 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | November 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150358
Locations
| Mexico | |
| Pfizer Investigational Site | |
| Torreon, Coahuila, Mexico, 72000 | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 07760 | |
| Pfizer Investigational Site | |
| Guadalajara, Jalisco, Mexico, 44290 | |
| Pfizer Investigational Site | |
| Colonia Centro, Mexico City, Mexico, 06090 | |
| Pfizer Investigational Site | |
| DF, Mexico City, Mexico, 06760 | |
| Pfizer Investigational Site | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Pfizer Investigational Site | |
| Monterrey, Nuevo Leon, Mexico, 64000 | |
| Pfizer Investigational Site | |
| Merida, Yucatan, Mexico, 97070 | |
| Pfizer Investigational Site | |
| Aguascalientes, Mexico, C.P. 20230 | |
| Pfizer Investigational Site | |
| Chihuahua, Mexico, 31238 | |
| Pfizer Investigational Site | |
| Durango, Mexico, 34300 | |
| Pfizer Investigational Site | |
| Metepec, Mexico, 52140 | |
| Pfizer Investigational Site | |
| Puebla, Mexico, 72090 | |
| Pfizer Investigational Site | |
| San Luis Potosi, Mexico, 78090 | |
| Pfizer Investigational Site | |
| San Luis PotosÃ, Mexico, 78240 | |
| Pfizer Investigational Site | |
| Veracruz, Mexico, C.P. 97897 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00150358 History of Changes |
| Other Study ID Numbers: | A1481187 |
| Study First Received: | September 6, 2005 |
| Last Updated: | December 7, 2006 |
| Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
Additional relevant MeSH terms:
|
Hypertension Erectile Dysfunction Vascular Diseases Cardiovascular Diseases Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Antihypertensive Agents |
Sildenafil Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013