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...
Date First Received: October 5, 2007
Last Updated: October 5, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: April 2001
Overall Status: Completed
Estimated Enrollment: 126
Brief Summary
Official Title: “A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension”
Condition Keyword(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0954, /Duration of Treatment : 16 Weeks
- Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- number of sexual intercourse events in a 2-week period
- Time Frame: 2 Weeks
- Time Frame: 2 Weeks
Secondary Measures
- sexual functioning score and overall sexual satisfaction score after 16 weeks
- Time Frame: 16 Weeks
- Time Frame: 16 Weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 49 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541684
Study ID Number: 2007_624
ClinicalTrials.gov Identifier: NCT00541684
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
MedWatch - FDA maintained medical product safety Information
PhRMA Clinical Study Results Database - web-based repository for clinical study results
Clinical Trials Authorship and Review
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