HypertensionPhase 3ALLAYNCT00219141
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
A Phase 3 study testing Aliskiren 150/300 mg and Losartan 50/100 mg in people with Hypertension and Left Ventricular Hypertrophy, run by Novartis Pharmaceuticals at 9 sites in 9 countries.
Trial summary
To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Left Ventricular Hypertrophy, Overweight
- What is being tested?
- Aliskiren 150/300 mg and Losartan 50/100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Oct 2005to Nov 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with essential hypertension
- Patients with a BMI > 25 kg/m2
- Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO
Who cannot join
- Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period.
- Patients treated with an ACE and ARB combination at study entry.
- Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).
- Other protocol related inclusion/exclusion criteria applied to the study.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A 36-week, Randomized, Double-blind, Multi-center, Parallel Group Study Comparing the Efficacy and Safety of Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.
- Conditions
- Hypertension, Left Ventricular Hypertrophy, Overweight
- Being tested
- Aliskiren 150/300 mg, Losartan 50/100 mg, Aliskiren placebo, Losartan 50/100 mg placebo
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren 150/300 mgDrug
Aliskiren 150 mg tablets
Losartan 50/100 mgDrug
Losartan 50 or 100 mg capsules
Aliskiren placeboDrug
Aliskiren 150 mg placebo tablet
Losartan 50/100 mg placeboDrug
Losartan 50/100 mg placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren 300 mg | Experimental | Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. Receives: Drug: Aliskiren 150/300 mg; Drug: Aliskiren placebo; Drug: Losartan 50/100 mg placebo |
| Losartan 100 mg | Active comparator | Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. Receives: Drug: Losartan 50/100 mg; Drug: Aliskiren placebo |
| Aliskiren/losartan 300/100 mg | Experimental | Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. Receives: Drug: Aliskiren 150/300 mg; Drug: Losartan 50/100 mg; Drug: Aliskiren placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
Measured: Baseline to end of study (Week 36)
Secondary outcomes (12)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
Measured: Baseline to end of study (Week 36)
Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.
Measured: Baseline the end of study (Week 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionNov 2007
- Study completionNov 2007
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219141
- Sponsor's protocol ID
- CSPP100A2316
- Acronym
- ALLAY
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 26 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.
PubMed 40013543Pouleur AC, Uno H, Prescott MF, Desai A, Appelbaum E, Lukashevich V, Smith BA, Dahlof B, Solomon SD; ALLAY Investigators. Suppression of aldosterone mediates regression of left ventricular hypertrophy in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2011 Dec;12(4):483-90. doi: 10.1177/1470320311414453. Epub 2011 Jul 11.
PubMed 21746765
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36-week, Randomized, Double-blind, Multi-center, Parallel Group Study Comparing the Efficacy and Safety of Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00219141
- Acronym / sponsor ID
- ALLAY / CSPP100A2316
- Conditions
- Hypertension, Left Ventricular Hypertrophy, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 10 May 2011
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 efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aliskiren 300 mg | Experimental | Drug: Aliskiren 150/300 mg, Drug: Aliskiren placebo, Drug: Losartan 50/100 mg placeboPatients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Losartan 100 mg | Active comparator | Drug: Losartan 50/100 mg, Drug: Aliskiren placeboPatients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Aliskiren/losartan 300/100 mg | Experimental | Drug: Aliskiren 150/300 mg, Drug: Losartan 50/100 mg, Drug: Aliskiren placeboPatients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with essential hypertension
- Patients with a BMI > 25 kg/m2
- Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO
Key exclusion criteria (4 listed)
- Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period.
- Patients treated with an ACE and ARB combination at study entry.
- Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).
- Other protocol related inclusion/exclusion criteria applied to the study.
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 |
|---|---|---|
| Aliskiren 150/300 mgAliskiren 150 mg tablets | Drug | Aliskiren 300 mg, Aliskiren/losartan 300/100 mg |
| Losartan 50/100 mgLosartan 50 or 100 mg capsules | Drug | Aliskiren/losartan 300/100 mg, Losartan 100 mg |
| Aliskiren placeboAliskiren 150 mg placebo tablet | Drug | Aliskiren 300 mg, Aliskiren/losartan 300/100 mg, Losartan 100 mg |
| Losartan 50/100 mg placeboLosartan 50/100 mg placebo capsules | Drug | Aliskiren 300 mg |
Primary outcome
Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
12 secondary outcomes
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
Time frame: Baseline to end of study (Week 36)
Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
Time frame: Baseline the end of study (Week 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40013543Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.
- Derived from this study: PubMed 21746765Pouleur AC, Uno H, Prescott MF, Desai A, Appelbaum E, Lukashevich V, Smith BA, Dahlof B, Solomon SD; ALLAY Investigators. Suppression of aldosterone mediates regression of left ventricular hypertrophy in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2011 Dec;12(4):483-90. doi: 10.1177/1470320311414453. Epub 2011 Jul 11.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren 150/300 mg and Losartan 50/100 mg in people with Hypertension and Left Ventricular Hypertrophy, run by Novartis Pharmaceuticals at 9 sites in 9 countries.
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 3 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 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Argentina, Colombia, Finland, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 10 May 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?
Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) (time frame: Baseline to end of study (Week 36)). 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 NCT00219141, which also lists 2 linked publications.
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 26 May 2011.