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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

Page last updated: June 20, 2008

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