HypertensionPhase 3EASENCT00546754
BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)
A Phase 3 study testing losartan potassium (+) hydrochlorothiazide and Comparator: Valsartan (+) Hydrochlorothiazide in people with Hypertension, run by Organon and Co.
Trial summary
To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- losartan potassium (+) hydrochlorothiazide and Comparator: Valsartan (+) Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2007to 1 May 2009
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An Adult Patient 18 to 75 Years Of Age
- Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
- Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
- Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
- Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
- Surgically sterilized female
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- Postmenopausal female > 45 years of age with > 2 years since her last menses
- Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy [either 2 barrier methods or a barrier method plus a hormonal method]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
- Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination
Who cannot join
- Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
- Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
- Patient taking allopurinol
- Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
- Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
- Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
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- Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
- Patient with symptomatic heart failure (classes 3 and 4)
- Patient with a history of stroke within the last 6 months
- Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
- Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
- Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
- Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.
About this study
Official title: BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With
To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.
- Conditions
- Hypertension
- Being tested
- losartan potassium (+) hydrochlorothiazide, Comparator: Valsartan (+) 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
losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
Comparator: Valsartan (+) HydrochlorothiazideDrug
Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug Arm Receives: Drug: losartan potassium (+) hydrochlorothiazide |
| 2 | Active comparator | active comparator Receives: Drug: Comparator: Valsartan (+) Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure From Baseline to Week 12
Measured: Baseline and Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12
Measured: Baseline and Week 12
Secondary outcomes (11)
Change in Systolic Blood Pressure From Baseline to Week 6
Measured: Baseline and Week 6
Change in Diastolic Blood Pressure From Baseline to Week 6
Measured: Baseline and Week 6
Number of Patients Achieving Target Blood Pressure at Week 6
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6
Measured: Week 6
Number of Patients Achieving Target Blood Pressure at Week 12
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12
Measured: 12 Weeks
Time to Achieve Target Blood Pressure
Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)
Measured: 12 weeks
Change in Uric Acid From Baseline to Week 6
Measured: Baseline and Week 6
Change in Uric Acid From Baseline to Week 12
Measured: Baseline and Week 12
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
Measured: Baseline and Week 6
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
Measured: Baseline and Week 12
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
Measured: Baseline and Week 6
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
Measured: 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 posted19 Oct 2007 (estimated)
- Study start1 May 2007
- Primary completion1 Apr 2009
- Study completion1 May 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 808 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
- NCT00546754
- Sponsor's protocol ID
- 0954A-333
- Other IDs
- MK0954A-333, 2007_031
- Acronym
- EASE
- Status last verified
- Feb 2022
- First submitted
- 17 Oct 2007
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With
- ClinicalTrials.gov ID
- NCT00546754
- Acronym / sponsor ID
- EASE / 0954A-333
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 May 2007 (actual)
- Primary completion
- 1 Apr 2009 (actual)
- Study completion
- 1 May 2009 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Posted 13 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: losartan potassium (+) hydrochlorothiazideDrug Arm |
| 2 | Active comparator | Drug: Comparator: Valsartan (+) Hydrochlorothiazideactive comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- An Adult Patient 18 to 75 Years Of Age
- Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
- Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
- Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
- Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
Key exclusion criteria (13 listed)
- Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
- Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
- Patient taking allopurinol
- Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
- Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
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 (+) hydrochlorothiazidelosartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide | Drug | 1 |
| Comparator: Valsartan (+) HydrochlorothiazideValsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide | Drug | 2 |
Primary outcome
Change in Systolic Blood Pressure From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12
Time frame: Baseline and Week 12
11 secondary outcomes
Change in Systolic Blood Pressure From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Diastolic Blood Pressure From Baseline to Week 6
Time frame: Baseline and Week 6
Number of Patients Achieving Target Blood Pressure at Week 6
Time frame: Week 6
Number of Patients Achieving Target Blood Pressure at Week 12
Time frame: 12 Weeks
Time to Achieve Target Blood Pressure
Time frame: 12 weeks
Change in Uric Acid From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Uric Acid From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
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 and Comparator: Valsartan (+) 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 9 inclusion and 13 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 16 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 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?
Yes. Results are posted in the registry (first posted 13 Apr 2010). 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?
Change in Systolic Blood Pressure From Baseline to Week 12 (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 16 May 2024.