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This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren 300 mg | Experimental | Aliskiren 300 mg once daily |
|
| Aliskiren 150 mg | Experimental | Aliskiren 150 mg once daily |
|
| Aliskiren 75 mg | Experimental | Aliskiren 75 mg once daily |
|
| Ramipril 5 mg | Active Comparator | Ramipril 5 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) | To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint | Baseline and Week 8 |
| Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) | To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint | Baseline and Week 8 |
| Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) | To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint | To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension. | Baseline and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Sites | China | China | ||||
| Novartis Investigative Sites |
| 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 300 mg | Aliskiren 300 mg once daily |
| FG001 | Aliskiren 150 mg | Aliskiren 150 mg once daily |
| FG002 | Aliskiren 75 mg | Aliskiren 75 mg once daily |
| FG003 | Ramipril 5 mg | Ramipril 5 mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren 300 mg | Aliskiren 300 mg once daily |
| BG001 | Aliskiren 150 mg | Aliskiren 150 mg once daily |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint | To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension. | Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
8 weeks
One randomized patient in the Ramipril group never received blinded study medication. The subject is therefore not included in the "at risk" population.
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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 | Aliskiren 300 mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Ramipril | Drug | comparator |
|
| Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg | To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg. | Week 8 |
| Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP | To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP. | Week 8 |
| India |
| India |
| Novartis Investigative Sites | Thailand | Thailand |
| Adverse Event |
|
| Unsatisfactory therapeutic response |
|
| Lost to Follow-up |
|
| Protocol deviation |
|
| Administrative problems |
|
| BG002 |
| Aliskiren 75 mg |
Aliskiren 75 mg once daily |
| BG003 | Ramipril 5 mg | Ramipril 5 mg once daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Aliskiren 150 mg once daily
| OG002 | Aliskiren 75 mg | Aliskiren 75 mg once daily |
| OG003 | Ramipril 5 mg | Ramipril 5 mg once daily |
|
|
| Secondary | Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg | To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg. | Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement. | Posted | Number | Percentage of participants | Week 8 |
|
|
|
| Secondary | Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP | To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP. | Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement. | Posted | Number | Percentage of participants | Week 8 |
|
|
|
| Primary | Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) | To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint | Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
|
|
|
| Primary | Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) | To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint | Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
|
|
|
| Primary | Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) | To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint | Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
|
|
|
| 1 |
| 331 |
| 4 |
| 331 |
| EG001 | Aliskiren 150 mg | Aliskiren 150 mg once daily | 2 | 323 | 3 | 323 |
| EG002 | Aliskiren 75 mg | Aliskiren 75 mg once daily | 3 | 332 | 2 | 332 |
| EG003 | Ramipril 5 mg | Ramipril 5 mg once daily | 1 | 329 | 17 | 329 |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Varicose vein | Vascular 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.