HypertensionPhase 3NCT00398541
Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients (0954A-322)
A Phase 3 study testing losartan potassium (+) hydrochlorothiazide in people with Hypertension, run by Organon and Co.
Trial summary
Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- losartan potassium (+) hydrochlorothiazide
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2005to 1 Jun 2007
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period
- Be able to carry out his or her own daily activity
- - Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated
- Literate
- Not taking any cognitive-enhanced agent at baseline
- Present with a memory complain ( spontaneous or informed by caregiver)
Who cannot join
- Congestive heart failure with NYHA class >2
- Renal failure or renal insufficiency with serum creatinine >1.4mg/dl
- chronic severe liver disease with abnormal GPT and GOT >2 times of upper normal limits
- Diagnosed with major depression when entering the study
- Foreign language as his or her mother tongue so that the test results will not be reliable
- History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise)
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- Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets
- Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests
- Myocardial infarction within the past 6 months
- Single functioning kidney
- Anuria
About this study
Official title: Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients
Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).
- Conditions
- Hypertension
- Being tested
- losartan potassium (+) hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losartan potassium (+) hydrochlorothiazideDrug
Also called MK954A, Hyzaar
losartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological tests and blood pressure after treatment of 12 weeks
Measured: after treatment of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study start1 Mar 2005
- Primary completion10 Apr 2007
- Study completion1 Jun 2007
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
- None (open label)
- Enrolment
- 41 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
- NCT00398541
- Sponsor's protocol ID
- 0954A-322
- Other IDs
- MK0954A-322, 2006_048
- Status last verified
- Feb 2022
- First submitted
- 9 Nov 2006
- 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
- Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00398541
- Acronym / sponsor ID
- 0954A-322
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2005 (actual)
- Primary completion
- 10 Apr 2007 (actual)
- Study completion
- 1 Jun 2007 (actual)
- First posted
- 10 Nov 2006 (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.
Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period
- Be able to carry out his or her own daily activity
- - Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated
- Literate
- Not taking any cognitive-enhanced agent at baseline
Key exclusion criteria (11 listed)
- Congestive heart failure with NYHA class >2
- Renal failure or renal insufficiency with serum creatinine >1.4mg/dl
- chronic severe liver disease with abnormal GPT and GOT >2 times of upper normal limits
- Diagnosed with major depression when entering the study
- Foreign language as his or her mother tongue so that the test results will not be reliable
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 |
|---|---|---|
| losartan potassium (+) hydrochlorothiazideAlso: MK954A, Hyzaarlosartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25 | Drug | – |
Primary outcome
Neuropsychological tests and blood pressure after treatment of 12 weeks
Time frame: after treatment of 12 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 losartan potassium (+) hydrochlorothiazide 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 6 inclusion and 11 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?
Neuropsychological tests and blood pressure after treatment of 12 weeks (time frame: after treatment of 12 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.