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...

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

Secondary Measures

  • sexual functioning score and overall sexual satisfaction score after 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 July 02, 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

Merck: Patient & Caregiver U.S. Product Web Site

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