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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren 150/300 mg | Drug | Aliskiren 150 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of study (Week 36) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol related inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States | ||
| sites in Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40013543 | Derived | 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. | |
| 21746765 | Derived | Pouleur 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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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren 300 mg | 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. |
| FG001 | Losartan 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Losartan 50/100 mg | Drug | Losartan 50 or 100 mg capsules |
|
| Aliskiren placebo | Drug | Aliskiren 150 mg placebo tablet |
|
| Losartan 50/100 mg placebo | Drug | Losartan 50/100 mg placebo capsules |
|
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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. | Baseline the end of study (Week 36) |
| Argentina |
| Argentina |
| sites in Colombia | Colombia | Colombia |
| sites in Finland | Finland | Finland |
| sites in Germany | Germany | Germany |
| sites in Italy | Italy | Italy |
| sites in Russia | Russia | Russia |
| sites in Spain | Spain | Spain |
| sites in Sweden | Sweden | Sweden |
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.
| FG002 | Aliskiren/Losartan 300/100 mg | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren 300 mg | 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. |
| BG001 | Losartan 100 mg | 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. |
| BG002 | Aliskiren/Losartan 300/100 mg | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | g/m^2 | Baseline to end of study (Week 36) |
|
|
| |||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Mean | Standard Deviation | g/m^2 | 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) | 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. | Posted | Mean | Standard Deviation | mL | 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) | 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. | Posted | Mean | Standard Deviation | mL | 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) | 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. | Posted | Mean | Standard Deviation | mm | 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) | 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. | Posted | Mean | Standard Deviation | mm | 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) | 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. | Posted | Mean | Standard Deviation | mm | 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) | 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. | Posted | Mean | Standard Deviation | g | 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) | 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. | Posted | Mean | Standard Deviation | percent | 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) | 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. | Posted | Mean | Standard Deviation | mL | Baseline to end of study (Week 36) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement. | Posted | Mean | Standard Deviation | mm | Baseline to end of study (Week 36) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) | Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement. | Posted | Mean | Standard Deviation | mm * ms | Baseline to end of study (Week 36) |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline the end of study (Week 36) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aliskiren 300 mg | 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. | 10 | 154 | 31 | 154 | ||
| EG001 | Losartan 100 mg | 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. | 13 | 152 | 31 | 152 | ||
| EG002 | Aliskiren/Losartan 300/100 mg | 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. | 10 | 154 | 29 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pelvic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D017379 | Hypertrophy, Left Ventricular |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C446481 | aliskiren |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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|---|---|
| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
|
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. |
|
|