Trial · NCT00219141
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
NCT00219141, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension. Trials, record NCT00219141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00219141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
- NCT number
- NCT00219141
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension, Left Ventricular Hypertrophy, Overweight
- Interventions
- Aliskiren 150/300 mg, Losartan 50/100 mg, Aliskiren placebo, Losartan 50/100 mg placebo
- First posted
- 2005-09-22
- Last updated
- 2011-05-26
- Results first posted
- 2011-05-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | 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. |
| Secondary | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | |
| Secondary | 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) | Baseline to end of study (Week 36) | |
| Secondary | 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) | Baseline to end of study (Week 36) | |
| Secondary | 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) | Baseline to end of study (Week 36) | |
| Secondary | 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) | Baseline to end of study (Week 36) | |
| Secondary | Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | |
| Secondary | 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) | Baseline to end of study (Week 36) | |
| Secondary | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | |
| Secondary | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | g/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | g/m^2 | MEAN |
| SECONDARY | 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) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | mL | MEAN |
| SECONDARY | 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) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | mL | MEAN |
| SECONDARY | 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) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | mm | MEAN |
| SECONDARY | 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) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | mm | MEAN |
| SECONDARY | Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | mm | MEAN |
| SECONDARY | 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) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | g | MEAN |
| SECONDARY | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | percent | MEAN |
| SECONDARY | Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) | Baseline to end of study (Week 36) | Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study. | mL | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | Aliskiren 300 mg | -5.51 | Standard Error 0.95 | g/m^2 | |
| Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | Losartan 100 mg | -4.81 | Standard Error 0.98 | g/m^2 | |
| Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) | Aliskiren/Losartan 300/100 mg | -5.61 | Standard Error 0.93 | g/m^2 | |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | Aliskiren 300 mg | -4.87 | Standard Deviation 11.69 | g/m^2 | |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | Losartan 100 mg | -4.79 | Standard Deviation 11.87 | g/m^2 | |
| Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) | Aliskiren/Losartan 300/100 mg | -5.81 | Standard Deviation 10.93 | g/m^2 | |
| 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) | Aliskiren 300 mg | -7.05 | Standard Deviation 24.09 | mL | |
| 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) | Losartan 100 mg | -4.52 | Standard Deviation 25.15 | mL | |
| 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) | Aliskiren/Losartan 300/100 mg | -7.03 | Standard Deviation 24.97 | mL | |
| 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) | Aliskiren 300 mg | -3.20 | Standard Deviation 16.64 | mL |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aliskiren 300 mg | 154 | |
| Overall Study | STARTED | Losartan 100 mg | 152 | |
| Overall Study | STARTED | Aliskiren/Losartan 300/100 mg | 154 | |
| Overall Study | COMPLETED | Aliskiren 300 mg | 140 | |
| Overall Study | COMPLETED | Losartan 100 mg | 131 | |
| Overall Study | COMPLETED | Aliskiren/Losartan 300/100 mg | 142 | |
| Overall Study | NOT COMPLETED | Aliskiren 300 mg | 14 | |
| Overall Study | NOT COMPLETED | Losartan 100 mg | 21 | |
| Overall Study | NOT COMPLETED | Aliskiren/Losartan 300/100 mg | 12 |
Source ClinicalTrials.gov
Adverse events156
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Aliskiren 300 mg | 6 | 154 | |
| other | Diarrhoea | Gastrointestinal disorders | Losartan 100 mg | 9 | 152 | |
| other | Diarrhoea | Gastrointestinal disorders | Aliskiren/Losartan 300/100 mg | 7 | 154 | |
| other | Nasopharyngitis | Infections and infestations | Aliskiren 300 mg | 11 | 154 | |
| other | Nasopharyngitis | Infections and infestations | Losartan 100 mg | 13 | 152 | |
| other | Nasopharyngitis | Infections and infestations | Aliskiren/Losartan 300/100 mg | 11 | 154 | |
| other | Dizziness | Nervous system disorders | Aliskiren 300 mg | 5 | 154 | |
| other | Dizziness | Nervous system disorders | Losartan 100 mg | 3 | 152 | |
| other | Dizziness | Nervous system disorders | Aliskiren/Losartan 300/100 mg | 8 | 154 | |
| other | Headache | Nervous system disorders | Aliskiren 300 mg | 14 | 154 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aliskiren 300 mg | ||
| Total, all-cause mortality | Losartan 100 mg | ||
| Total, all-cause mortality | Aliskiren/Losartan 300/100 mg | ||
| Total, other adverse events | Aliskiren 300 mg | 31 | 154 |
| Total, other adverse events | Losartan 100 mg | 31 | 152 |
| Total, other adverse events | Aliskiren/Losartan 300/100 mg | 29 | 154 |
| Total, serious adverse events | Aliskiren 300 mg | 10 | 154 |
| Total, serious adverse events | Losartan 100 mg | 13 | 152 |
| Total, serious adverse events | Aliskiren/Losartan 300/100 mg | 10 | 154 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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