Health Assessment Study (0954-946)

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0954, /Duration of Treatment : 16 Weeks

Drug

Comparator : atenolol /Duration of Treatment : 16 Weeks

Drug

Primary outcomes

number of sexual intercourse events in a 2-week period

Time frame: 2 Weeks

Secondary outcomes

sexual functioning score and overall sexual satisfaction score after 16 weeks

Time frame: 16 Weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2003
First posted: Oct 10, 2007
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed