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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001242-10 | EudraCT Number |
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This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren/Amlodipine/Hydrochlorothiazide | Experimental | Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | 300 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death | An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above. | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. |
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Inclusion Criteria:
Outpatients 18 years of age or older
Male or female participants are eligible.
Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:
For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Houston | Texas | United States | |||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23205748 | Result | Murray AV, Koenig W, Garcia-Puig J, Patel S, Uddin A, Zhang J. Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study. J Clin Hypertens (Greenwich). 2012 Dec;14(12):821-7. doi: 10.1111/j.1751-7176.2012.00706.x. Epub 2012 Aug 28. |
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A total of 635 participants entered the washout period, of which 564 participants met the study entry criteria and entered the study treatment phase.
Participants with essential hypertension were enrolled in the study at 82 investigative sites worldwide from 5 June 2008 to 5 October 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren /Amlodipine/Hydrochlorothiazide | Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amlodipine |
| Drug |
5 mg tablet |
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| Hydrochlorothiazide | Drug | 12.5 mg and 25 mg capsule |
|
| Baseline, Weeks 28 and 54 endpoint |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Baseline, Weeks 28 and 54 endpoints |
| Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg | Blood pressure control was defined as having a mean sitting diastolic blood pressure <90 mmHg and a mean sitting systolic blood pressure <140 mmHg. Percentage of participants achieving the blood pressure control of < 140/90 mmHg were reported. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28 and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Weeks 28 and 54 endpoints |
| Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure | Diastolic Blood pressure response was defined as a mean sitting diastolic blood pressure <90 mmHg or a >=10 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Weeks 28 and 54 endpoints |
| Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure | Systolic blood pressure response was defined as a mean sitting systolic blood pressure <140 mmHg or a >=20 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Weeks 28 and 54 endpoints |
| Belgium |
| Belgium |
| Investigative Site | Egypt | Egypt |
| Investigative Site | Germany | Germany |
| Investigative Site | Poland | Poland |
| Investigative Site | Slovakia | Slovakia |
| Investigative Site | Spain | Spain |
| Investigative Site | Turkey | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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Treated Population consisted of all participants who received at least one dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren /Amlodipine/Hydrochlorothiazide | Participants received aliskiren 300 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death | An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above. | Treated Population consisted of all participants who received at least one dose of trial medication. | Posted | Count of Participants | Participants | 54 weeks |
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| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Treated Population consisted of all participants who received at least one dose of trial medication. Number analyzed is the number of participants with data available at both baseline and post-baseline time points. | Posted | Mean | Standard Deviation | mmHg | Baseline, Weeks 28 and 54 endpoint |
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| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Treated Population consisted of all participants who received at least one dose of trial medication. Number analyzed is the number of participants with data available at both baseline and post-baseline time points. | Posted | Mean | Standard Deviation | millimeters of mercury | Baseline, Weeks 28 and 54 endpoints |
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| Secondary | Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg | Blood pressure control was defined as having a mean sitting diastolic blood pressure <90 mmHg and a mean sitting systolic blood pressure <140 mmHg. Percentage of participants achieving the blood pressure control of < 140/90 mmHg were reported. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28 and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Treated Population consisted of all participants who received at least one dose of trial medication. Number analyzed is the number of participants with data available at specified time points. | Posted | Number | percentage of participants | Weeks 28 and 54 endpoints |
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| Secondary | Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure | Diastolic Blood pressure response was defined as a mean sitting diastolic blood pressure <90 mmHg or a >=10 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Treated Population consisted of all participants who received at least one dose of trial medication. Number analyzed is the number of participants with data available at both baseline and post-baseline time points. | Posted | Number | percentage of participants | Weeks 28 and 54 endpoints |
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| Secondary | Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure | Systolic blood pressure response was defined as a mean sitting systolic blood pressure <140 mmHg or a >=20 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. | Treated Population consisted of all participants who received at least one dose of trial medication. Number analyzed is the number of participants with data available at both baseline and post-baseline time points. | Posted | Number | percentage of participants | Weeks 28 and 54 endpoints |
|
|
From Baseline up to 54 weeks.
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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/Hydrochlorothiazide 300/12.5 mg | Participants received aliskiren 300 mg plus hydrochlorothiazide 12.5 mg, orally with water, once daily in the morning, for one week, at Week 1. | 0 | 564 | 0 | 564 | 21 | 564 |
| EG001 | Aliskiren/Amlodipine/Hydrochlorothiazide 300/5/12.5 mg | Following Week 1, participants received combination of aliskiren 300 mg plus amolodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. All study medications were taken orally with water, once daily in the morning. | 0 | 561 | 1 | 561 | 14 | 561 |
| EG002 | Aliskiren/Amlodipine/Hydrochlorothiazide 300/10/25 mg | Following Week 2, participants were force titrated up to aliskiren 300 mg plus amolodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning. | 0 | 556 | 14 | 556 | 141 | 556 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
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| Drug dependence | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (unspecified) | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (unspecified) | 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 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D017311 | Amlodipine |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Death |
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