HypertensionPhase 3NCT00739674
SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
A Phase 3 study testing losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) and Low Salt Diet in people with Hypertension, run by Organon and Co.
Trial summary
To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) and Low Salt Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2008to 1 Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)
- Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
- Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg
- The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug
Who cannot join
- Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
- Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
- Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
- Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
About this study
Official title: Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.
To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.
- Conditions
- Hypertension
- Being tested
- losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]), Low Salt Diet
- 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 (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])Drug
Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows:
Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes:
- Losartan 50 mg
- Losartan 100 mg
- Losartan 100 mg/HCTZ 12.5 mg
- Losartan 100 mg/HCTZ 25 mg
- Losartan 100 mg/HCTZ 25 mg + CCB
Patients with severe hypertension:
- Losartan 50 mg/HCTZ 12.5 mg
- Losartan 100 mg/HCTZ 12.5 mg
- Losartan 100 mg/HCTZ 25 mg
- Losartan 100 mg/HCTZ 25 mg + CCB
- Losartan 100 mg/HCTZ 25 mg + increasing CCB
Low Salt DietBehavioural
Low-salt intake diet (Dietary Approaches to Stop Hypertension [DASH]) including:
- Healthy diet
- Reduction in sodium intake to less than 2300 mmol/day
- Low alcohol consumption (less than 2 standard drinks/day)
| Study group | Role | What they receive |
|---|---|---|
| Losartan-Based Regimen Alone (L Group) | Active comparator | Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure. Receives: Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) |
| Diet Management and Losartan-Based Regimen (DML Group) | Experimental | Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet. Receives: Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Behavioral: Low Salt Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Measured: 14 Weeks
Change in Systolic Blood Pressure From Baseline to Week 14
Measured: 14 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 14
Measured: 14 Weeks
Secondary outcomes (8)
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment
Measured: 6 Weeks
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment
Measured: 10 Weeks
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment
Measured: 40 Weeks
Change in Systolic Blood Pressure From Baseline to Week 6
Measured: 6 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 6
Measured: 6 Weeks
Change in Systolic Blood Pressure From Baseline to Week 10
Measured: 10 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 10
Measured: 10 Weeks
Time to Achieve the Target Blood Pressure From Baseline
Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).
Measured: 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study start1 Feb 2008
- Primary completion1 Jul 2009
- Study completion1 Jan 2010
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
- 992 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
- NCT00739674
- Sponsor's protocol ID
- 0954A-335
- Other IDs
- 2008_022, MK0954A-335
- Status last verified
- Feb 2022
- First submitted
- 20 Aug 2008
- 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
- Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.
- ClinicalTrials.gov ID
- NCT00739674
- Acronym / sponsor ID
- 0954A-335
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2008 (actual)
- Primary completion
- 1 Jul 2009 (actual)
- Study completion
- 1 Jan 2010 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 11 Aug 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 effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan-Based Regimen Alone (L Group) | Active comparator | Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure. |
| Diet Management and Losartan-Based Regimen (DML Group) | Experimental | Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]), Behavioral: Low Salt DietLosartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)
- Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
- Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg
- The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug
Key exclusion criteria (4 listed)
- Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
- Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
- Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
- Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
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 (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows: Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes: * Losartan 50 mg * Losartan 100 mg * Losartan 100 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 25 mg * Losartan 100 mg/HCTZ 25 mg + CCB Patients with severe hypertension: * Losartan 50 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 25 mg * Losartan 100 mg/HCTZ 25 mg + CCB * Losartan 100 mg/HCTZ 25 mg + increasing CCB | Drug | Diet Management and Losartan-Based Regimen (DML Group), Losartan-Based Regimen Alone (L Group) |
| Low Salt DietLow-salt intake diet (Dietary Approaches to Stop Hypertension [DASH]) including: * Healthy diet * Reduction in sodium intake to less than 2300 mmol/day * Low alcohol consumption (less than 2 standard drinks/day) | Behavioural | Diet Management and Losartan-Based Regimen (DML Group) |
Primary outcome
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
Time frame: 14 Weeks
Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Change in Systolic Blood Pressure From Baseline to Week 14
Time frame: 14 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 14
Time frame: 14 Weeks
8 secondary outcomes
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
Time frame: 6 Weeks
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
Time frame: 10 Weeks
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
Time frame: 40 Weeks
Change in Systolic Blood Pressure From Baseline to Week 6
Time frame: 6 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 6
Time frame: 6 Weeks
Change in Systolic Blood Pressure From Baseline to Week 10
Time frame: 10 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 10
Time frame: 10 Weeks
Time to Achieve the Target Blood Pressure From Baseline
Time frame: 14 Weeks
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 [HCTZ] + calcium channel blocker [CCB]) and Low Salt Diet 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 4 inclusion and 4 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 11 Aug 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?
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline (time frame: 14 Weeks). The study lists 3 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.