Mild to Severe HypertensionPhase 3NCT00307060
MK0954A-264 Filter Study (0954A-264)(COMPLETED)
A Phase 3 study testing MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks and losartan / Duration of Treatment: 6 weeks in people with Mild to Severe Hypertension, run by Organon and Co.
Trial summary
To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Severe Hypertension
- What is being tested?
- MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks and losartan / Duration of Treatment: 6 weeks
- How many people
- 274 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2004to 2 Jun 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)
Who cannot join
- Systolic BP > 200 mmHg
- Secondary or malignant hypertension
- Taking more than 2 antihypertensive medications
- Hypertension induced by oral contraceptives
- Hx of cerebral vascular accident within 6 months
- Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
Show all 10Show fewer
- Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
- History of angioedema
- Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function
- Pregnancy or lactation.
About this study
Official title: A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension
To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.
- Conditions
- Mild to Severe Hypertension
- Being tested
- MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks, losartan / Duration of Treatment: 6 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeksDrug
losartan / Duration of Treatment: 6 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment.
Measured: 6 Weeks
Secondary outcomes (1)
Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study start1 Dec 2004
- Primary completion1 Jun 2005
- Study completion2 Jun 2005
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 Mild to Severe 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
- 274 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
- NCT00307060
- Sponsor's protocol ID
- 0954A-264
- Other IDs
- 2006_019
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2006
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Gleim GW, Rubino J, Zhang H, Shahinfar S, Soffer BA, Lyle PA, Littlejohn TW 3rd, Feig PU. A multicenter, randomized, double-blind, parallel-group trial of the antihypertensive efficacy and tolerability of a combination of once-daily losartan 100 mg/hydrochlorothiazide 12.5 mg compared with losartan 100-mg monotherapy in the treatment of mild to severe essential hypertension. Clin Ther. 2006 Oct;28(10):1639-48. doi: 10.1016/j.clinthera.2006.10.014.
PubMed 17157119
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, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00307060
- Acronym / sponsor ID
- 0954A-264
- Conditions
- Mild to Severe Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2004 (actual)
- Primary completion
- 1 Jun 2005 (actual)
- Study completion
- 2 Jun 2005 (actual)
- First posted
- 27 Mar 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.
To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)
Key exclusion criteria (10 listed)
- Systolic BP > 200 mmHg
- Secondary or malignant hypertension
- Taking more than 2 antihypertensive medications
- Hypertension induced by oral contraceptives
- Hx of cerebral vascular accident within 6 months
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 / Duration of Treatment: 6 weeks | Drug | – |
| losartan / Duration of Treatment: 6 weeks | Drug | – |
Primary outcome
Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment.
Time frame: 6 Weeks
1 secondary outcome
Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable.
Time frame: 6 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.
- Background: PubMed 17157119Gleim GW, Rubino J, Zhang H, Shahinfar S, Soffer BA, Lyle PA, Littlejohn TW 3rd, Feig PU. A multicenter, randomized, double-blind, parallel-group trial of the antihypertensive efficacy and tolerability of a combination of once-daily losartan 100 mg/hydrochlorothiazide 12.5 mg compared with losartan 100-mg monotherapy in the treatment of mild to severe essential hypertension. Clin Ther. 2006 Oct;28(10):1639-48. doi: 10.1016/j.clinthera.2006.10.014.
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 / Duration of Treatment: 6 weeks and losartan / Duration of Treatment: 6 weeks in people with Mild to Severe 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 1 inclusion and 10 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?
Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment. (time frame: 6 Weeks). 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 NCT00307060, 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 Aug 2024.