Health Assessment Study (0954-946)

August 13, 2024 updated by: Organon and Co

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 Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 49 years (Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of sexual intercourse events in a 2-week period Time Frame: 2 Weeks	2 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
sexual functioning score and overall sexual satisfaction score after 16 weeks Time Frame: 16 Weeks	16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

MedWatch - FDA maintained medical product safety Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2001

Primary Completion (Actual)

January 23, 2003

Study Completion (Actual)

January 23, 2003

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria