Health Assessment Study (0954-946)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: MK0954, /Duration of Treatment : 16 Weeks; Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541684

2007_624

0954-946

Details and patient eligibility

About

The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.

Enrollment: 143 patients

Sex: Male

Ages: 40 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed with mild to moderate hypertension\
• Married male in stable heterosexual relationship
• No prior history of sexual dysfunction
• Satisfied with overall sex life
• Patient's spouse is in close proximity for the study
• Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start
• Patient able to visit doctor in the morning of each scheduled visit
• Able to complete the self administered health assessment questionnaire

Exclusion criteria

• Hypertension due to cancer, history of heart or circulatory problems
• History of mental disorder that might impair sexual function
• History or presence of drug or alcohol abuse
• Prior surgery for erectile dysfunction or other urological procedure
• No penile implant or assist devices
• History of chronic liver disease, history of diabetes
• History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
• Subjects with only 1 kidney
• Mental handicap or legal incapacity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind