Health Assessment Study
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...
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”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00541684
