HypertensionPhase 3NCT00092209
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
A Phase 3 study testing MK0954A, hydrochlorothiazide (+) losartan potassium in people with Hypertension, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone. Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- MK0954A, hydrochlorothiazide (+) losartan potassium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 840 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Nov 2002
- 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 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese ancestry
- Stable high blood pressure defined by the study criteria
Who cannot join
- Pregnant or nursing
- Significant concurrent kidney, liver, blood, or other disease
- Recent heart attack or heart surgery
- History of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias
- Significant lab abnormalities
- Uncontrolled blood sugar
- History of certain drug allergies
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Study of the Anti-Hypertensive Efficacy and Safety of Losartan Monotherapy as Compared to HCTZ Monotherapy and to the Combination of Losartan and HCTZ in Japanese Patients With Essential Hypertension
The purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.
Read the detailed description
The duration of treatment is 3.5 months.
- Conditions
- Hypertension
- Being tested
- MK0954A, hydrochlorothiazide (+) losartan potassium, Comparator: placebo, losartan, hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0954A, hydrochlorothiazide (+) losartan potassiumDrug
Comparator: placebo, losartan, hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean trough SiDBP after 8 weeks of treatment
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2004 (estimated)
- Study startApr 2002
- Primary completionNov 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 840 participants
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
- NCT00092209
- Sponsor's protocol ID
- 0954A-302
- Other IDs
- 2004_065
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2004
- Last updated
- 15 Feb 2022
- Results posted
- No
Publications
Saruta T, Ogihara T, Matsuoka H, Suzuki H, Toki M, Hirayama Y, Nonaka K, Takahashi K. Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension. Hypertens Res. 2007 Aug;30(8):729-39. doi: 10.1291/hypres.30.729.
PubMed 17917321
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel Study of the Anti-Hypertensive Efficacy and Safety of Losartan Monotherapy as Compared to HCTZ Monotherapy and to the Combination of Losartan and HCTZ in Japanese Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00092209
- Acronym / sponsor ID
- 0954A-302
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 24 Sep 2004 (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 purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.
Detailed description
The duration of treatment is 3.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese ancestry
- Stable high blood pressure defined by the study criteria
Key exclusion criteria (7 listed)
- Pregnant or nursing
- Significant concurrent kidney, liver, blood, or other disease
- Recent heart attack or heart surgery
- History of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias
- Significant lab abnormalities
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 |
|---|---|---|
| MK0954A, hydrochlorothiazide (+) losartan potassium | Drug | – |
| Comparator: placebo, losartan, hydrochlorothiazide | Drug | – |
Primary outcome
Mean trough SiDBP after 8 weeks of treatment
1 secondary outcome
Safety
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 Feb 2022.
- Background: PubMed 17917321Saruta T, Ogihara T, Matsuoka H, Suzuki H, Toki M, Hirayama Y, Nonaka K, Takahashi K. Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension. Hypertens Res. 2007 Aug;30(8):729-39. doi: 10.1291/hypres.30.729.
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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 MK0954A, hydrochlorothiazide (+) losartan potassium 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 2 inclusion and 7 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 Feb 2022. 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?
Mean trough SiDBP after 8 weeks of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00092209, which also lists 1 linked publication.
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 Feb 2022.