Health Assessment Study
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: MK0954, /Duration of Treatment : 16 Weeks (Drug); Comparator : atenolol /Duration of Treatment : 16 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: number of sexual intercourse events in a 2-week period
Secondary outcome: sexual functioning score and overall sexual satisfaction score after 16 weeks
Eligibility
Minimum age: 40 Years.
Maximum age: 49 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: April 2001
Ending date: September 2002
Last updated: October 5, 2007
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