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Health Assessment Study (0954-946)

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00541684
Enrollment
143
Registered
2007-10-10
Start date
2001-07-11
Completion date
2003-01-23
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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.

Interventions

DRUGMK0954, /Duration of Treatment : 16 Weeks
DRUGComparator : atenolol /Duration of Treatment : 16 Weeks

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
40 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
number of sexual intercourse events in a 2-week period2 Weeks

Secondary

MeasureTime frame
sexual functioning score and overall sexual satisfaction score after 16 weeks16 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026