HypertensionPhase 4NCT01431508
A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)
A Phase 4 study testing Losartan 50 mg / HCTZ 12.5 mg in people with Hypertension, run by Organon and Co.
Trial summary
This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan 50 mg / HCTZ 12.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 1 Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant will have reached the legal age by the time of entrance into the run-in period.
- Participant has no active medical problem, other than essential hypertension,
- which might of itself or by this treatment significantly affect the Participant's blood pressure.
- Participants diagnosed with mild to moderate essential hypertension or
- hypertension accompanying with established cardiovascular (CV) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal.
- Note: For essential hypertension, the goal is to reduce the blood pressure to less than 140/90. For hypertension with established CV and renal diseases, the BP goal is < 130/80. (According to 2007 European Society of Hypertension (ESH) - European Society of Cardiology (ESC) guideline)
- Participant is either receiving antihypertensive therapy or no treatment.
- Participants with stable diabetes mellitus may enter the study.
Who cannot join
- Pregnant or lactating females.
- Secondary hypertension of any etiology (such as unilateral or bilateral renal
- disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).
- History of malignant hypertension.
- Sitting systolic blood pressure >210 mmHg at Visit 1 (Day 0).
- Participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1.
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- A clinically confirmed myocardial infarction within the recent 3 months.
- Angina pectoris.
- Clinically important cardiac arrhythmia.
- History of unexplained syncope within the prior 2 years, or a known syncopal
- disorder.
- Presence of hemodynamically significant obstructive valvular disease of
- cardiomyopathy.
- Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1.
- Participant with a single functioning kidney.
About this study
Official title: An Open-label, Single Arm, Prospective Study to Evaluate the Safety and Anti-hypertensive Efficacy of Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg Combination in Patients With Mild to Moderate Essential Hypertension
This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.
- Conditions
- Hypertension
- Being tested
- Losartan 50 mg / HCTZ 12.5 mg
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan 50 mg / HCTZ 12.5 mgDrug
Also called MK-0954A
Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Losartan 50 mg / HCTZ 12.5 mg | Experimental | Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks. Receives: Drug: Losartan 50 mg / HCTZ 12.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.
Measured: At Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study start1 Aug 2007
- Primary completion1 Jun 2009
- Study completion1 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Du-Yi Lee, M.D., Principal investigator, Cheng Ching General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431508
- Sponsor's protocol ID
- 0954A-373
- Status last verified
- Feb 2022
- First submitted
- 7 Sep 2011
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm, Prospective Study to Evaluate the Safety and Anti-hypertensive Efficacy of Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg Combination in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT01431508
- Acronym / sponsor ID
- 0954A-373
- Conditions
- Hypertension
- Keywords
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 22 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Losartan 50 mg / HCTZ 12.5 mg | Experimental | Drug: Losartan 50 mg / HCTZ 12.5 mgParticipants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant will have reached the legal age by the time of entrance into the run-in period.
- Participant has no active medical problem, other than essential hypertension,
- which might of itself or by this treatment significantly affect the Participant's blood pressure.
- Participants diagnosed with mild to moderate essential hypertension or
- hypertension accompanying with established cardiovascular (CV) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal.
Key exclusion criteria (15 listed)
- Pregnant or lactating females.
- Secondary hypertension of any etiology (such as unilateral or bilateral renal
- disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).
- History of malignant hypertension.
- Sitting systolic blood pressure >210 mmHg at Visit 1 (Day 0).
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 50 mg / HCTZ 12.5 mgAlso: MK-0954ALosartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks | Drug | Losartan 50 mg / HCTZ 12.5 mg |
Primary outcome
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: At Baseline and Week 12
Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Du-Yi Lee, M.D. principal investigator
Cheng Ching General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan 50 mg / HCTZ 12.5 mg 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 15 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 22 May 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 (time frame: At Baseline and Week 12). 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 22 May 2024.