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Early termination resulted from interim analysis of the ALTITUDE trial
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Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.
Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren | Experimental | Part 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase (period 1) consisting of treatment with one tablet of placebo to aliskiren once daily (o.d.). This was followed by a 4 week treatment phase (period 2) consisting of treatment with 300 mg aliskiren o.d.. Part 2: Eligible randomized patients in this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks. |
|
| Amlodipine | Active Comparator | Part 1: After aliskiren treatment (period 2), each patient was entered into a second washout period (4 weeks) during which blood pressure was required to be ≤ 140/90 mmHg. If blood pressure exceeded 140/90 mmHg on two consecutive days (home monitoring) and was confirmed at the study center, the patient was entered into the amlodipine treatment period (period 3). In period 3, all patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. Part 2: Eligible patients randomized to part 2 received amlodipine 5 mg o.d. and aliskiren placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | 300 mg tablet once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42). | Day 42 |
| Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98). | Day 98 |
| Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Day 42 |
| Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Day 98 |
| Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period | Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle) | Day 14 and Day 98 | |
| Part 2: Change From Baseline in Official Blood Pressure | Placebo Baseline (Day 14), Active Treatment (Day 98) |
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Inclusion criteria:
PART 1:
PART 2:
Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:
Exclusion criteria:
PART 1
PART 2
Other protocol-defined inclusion/exclusion criteria applied
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Buch | 13125 | Germany | |||
| Novartis Investigative Site |
Total 46 patients entered into the study; 10 patients in part 1 received study drug. 36 patients enrolled into part 2 and and 16 patients received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase. Part 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1, Period 1:Placebo Run-in(2 Weeks) |
|
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| Amlodipine | Drug | 5 mg capsule once daily |
|
| Placebo of Aliskiren | Drug | Matching placebo of aliskiren 300 mg tablet |
|
| Placebo of amlodipine | Drug | Matching placebo of amlodipine 5 mg capsule |
|
| Day 42 |
| Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period | Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration. | Day 42 |
| Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period | Day 42 |
| Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period | Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). | Day 42 |
| Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period | Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98). | Day 98 |
| Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Day 42 |
| Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Day 98 |
| Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period | Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration). | Day 42 |
| Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period | Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration). | Day 98 |
| Part 1: Renin Activity From Plasma During Aliskiren Treatment Period | Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay. | Day 42 |
| Part 1: Renin Activity From Plasma During Amlodipine Treatment Period | Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay. | Day 98 |
| Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Placebo Baseline (Day 14), Active Treatment (Day 98) |
| Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period | Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98). | Placebo Baseline (Day 14), Active Treatment (Day 98) |
| Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period | Day 98 |
| Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period | Day 98 |
| Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid | Placebo Baseline (Day 14), Active Treatment (Day 98) |
| Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle) | Placebo Baseline (Day 14), Active Treatment (Day 98) |
| Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies) | Placebo Baseline (Day 14), Active Treatment (Day 98) |
| Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death | 98 days |
| Hanover |
| 30159 |
| Germany |
| Aliskiren |
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d.. Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks |
| FG002 | Amlodipine | Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
| Part 1, Period 2: Aliskiren (4 Weeks) |
|
| Part 1, Period 3: Amlodipine (4-8 Weeks) |
|
| Part 2: Placebo Run-in (2 Weeks) |
|
|
| Part 2: Double Blind (12 Weeks) |
|
Part 1 : Baseline measures are on all patients.
Part 2: Randomized population of double-blind period used for Baseline/Demographic measurements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Placebo/Aliskiren/Amlodipine | Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase. Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d.. Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. |
| BG001 | Part 2, Double Blind Period: Aliskiren | Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks |
| BG002 | Part 2, Double Blind: Amlodipine | Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 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 | Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42). | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 42 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98). | Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes. | Posted | Day 98 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle) | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Day 14 and Day 98 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Official Blood Pressure | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Placebo Baseline (Day 14), Active Treatment (Day 98) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Placebo Baseline (Day 14), Active Treatment (Day 98) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Due to technical limitations, zero flow concentrations could not be derived for Ang II. | Posted | Day 42 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Due to technical limitations, zero flow concentrations could not be derived for Ang II. | Posted | Day 98 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period | Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis. | Posted | Mean | Standard Deviation | ng/g | Day 42 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period | Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration. | More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received. | Posted | Day 42 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period | Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points. | Posted | Day 42 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period | Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 42 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period | Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98). | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 98 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis. | Posted | Geometric Mean | 95% Confidence Interval | fmol/mL | Day 42 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis. | Posted | Geometric Mean | 95% Confidence Interval | fmol/mL | Day 98 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period | Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration). | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Day 42 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period | Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration). | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Day 98 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Renin Activity From Plasma During Aliskiren Treatment Period | Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay. | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis. | Posted | Geometric Mean | 95% Confidence Interval | ng/nl/h | Day 42 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 1: Renin Activity From Plasma During Amlodipine Treatment Period | Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay. | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis. | Posted | Geometric Mean | 95% Confidence Interval | ng/nl/h | Day 98 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Placebo Baseline (Day 14), Active Treatment (Day 98) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period | Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98). | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Placebo Baseline (Day 14), Active Treatment (Day 98) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Day 98 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Day 98 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle) | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Placebo Baseline (Day 14), Active Treatment (Day 98) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies) | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | Posted | Placebo Baseline (Day 14), Active Treatment (Day 98) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death | The safety population consisted of all patients who received at least one dose of study drug with at least one post-baseline safety assessment. Patients were analyzed according to treatment received. | Posted | Number | Participants | 98 days |
|
|
Not provided
The Safety Population consisted of all patients that received at least one dose of study drug with at least one post-baseline safety assessment.
In Part 1 of the study, no events were reported in period 1 when patients received placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Aliskiren | All eligible patients received 4 week treatment of 300 mg aliskiren o.d.. | 1 | 10 | 6 | 10 | ||
| EG001 | Part 1: Amlodipine | All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. | 0 | 10 | 3 | 10 | ||
| EG002 | Part 2: Placebo run-in Period | After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase. | 1 | 36 | 1 | 36 | ||
| EG003 | Part 2: Aliskiren | Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks | 0 | 8 | 2 | 8 | ||
| EG004 | Part 2: Amlodipine | Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks | 0 | 8 | 3 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MUSCLE HAEMORRHAGE | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| IRRITABILITY | General disorders | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue 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 or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C446481 | aliskiren |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Abnormal test procedure |
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| Administrative problems |
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| Part 2, Double blind |
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| Male |
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