NCT00541684CompletedPhase 3
A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 143
- Primary Endpoint
- number of sexual intercourse events in a 2-week period
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 49 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
number of sexual intercourse events in a 2-week period
Time Frame: 2 Weeks
Secondary Outcomes
- sexual functioning score and overall sexual satisfaction score after 16 weeks(16 Weeks)
Investigators
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