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Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren-based regimen | Experimental | Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg |
|
| Ramipril-based regimen | Active Comparator | Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Cough | Weeks 12 and 36 | |
| Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints | Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33089502 | Derived | Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren Based Treatment Regimen | Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg |
| FG001 | Ramipril Based Treatment Regimen | Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren Based Treatment Regimen | Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 | Intent to treat (ITT), Last Observation Carried forward (LOCF) | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 12 |
|
36 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 | Aliskiren based regimen |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novaris Phamaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000092244 | Isolated Systolic Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000075222 | Essential Hypertension |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D017257 | Ramipril |
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
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| Ramipril | Drug | Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning |
|
| Hydrochlorothiazide | Drug | Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning |
|
| Amlodipine | Drug | Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning |
|
| Weeks 12 and 36 |
| Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36 | Baseline and week 36 |
| Unsatisfactory therapeutic effect |
|
| Protocol deviation |
|
| Patient withdrew consent |
|
| Lost to Follow-up |
|
| Ramipril Based Treatment Regimen |
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Patients With Cough | Safety population | Posted | Number | Percentage of Participants | Weeks 12 and 36 |
|
|
|
| Secondary | Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints | Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg | intent to treat (ITT), last observation carried forward (LOCF) | Posted | Number | Percentage of participants | Weeks 12 and 36 |
|
|
|
| Secondary | Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36 | Intent to treat (ITT), Last Observation Carried forward (LOCF) | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and week 36 |
|
|
|
| 35 |
| 452 |
| 170 |
| 452 |
| EG001 | Ramipril | Ramipril based regimen | 27 | 444 | 181 | 444 |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Trifascicular block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye movement disorder | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Aphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Myringitis bullous | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pancreatic carcinoma | 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 |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal 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.
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |