HypertensionPhase 3NCT00541684
Health Assessment Study (0954-946)
A Phase 3 study testing MK0954, /Duration of Treatment : 16 Weeks and Comparator : atenolol /Duration of Treatment : 16 Weeks in people with Hypertension, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 49 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- MK0954, /Duration of Treatment : 16 Weeks and Comparator : atenolol /Duration of Treatment : 16 Weeks
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2001to 23 Jan 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
- Subjects with only 1 kidney
- Mental handicap or legal incapacity
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- MK0954, /Duration of Treatment : 16 Weeks, Comparator : atenolol /Duration of Treatment : 16 Weeks
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0954, /Duration of Treatment : 16 WeeksDrug
Comparator : atenolol /Duration of Treatment : 16 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sexual intercourse events in a 2-week period
Measured: 2 Weeks
Secondary outcomes (1)
sexual functioning score and overall sexual satisfaction score after 16 weeks
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study start11 Jul 2001
- Primary completion23 Jan 2003
- Study completion23 Jan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541684
- Sponsor's protocol ID
- 0954-946
- Other IDs
- 2007_624
- Status last verified
- Feb 2022
- First submitted
- 5 Oct 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00541684
- Acronym / sponsor ID
- 0954-946
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2001 (actual)
- Primary completion
- 23 Jan 2003 (actual)
- Study completion
- 23 Jan 2003 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK0954, /Duration of Treatment : 16 Weeks | Drug | – |
| Comparator : atenolol /Duration of Treatment : 16 Weeks | Drug | – |
Primary outcome
number of sexual intercourse events in a 2-week period
Time frame: 2 Weeks
1 secondary outcome
sexual functioning score and overall sexual satisfaction score after 16 weeks
Time frame: 16 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0954, /Duration of Treatment : 16 Weeks and Comparator : atenolol /Duration of Treatment : 16 Weeks in people with Hypertension, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of sexual intercourse events in a 2-week period (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.