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This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren 300 mg/Amlodipine 5 mg | Experimental | Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. |
|
| Aliskiren 300 mg/Amlodipine 10 mg | Experimental | Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. |
|
| Aliskiren 300 mg | Active Comparator | Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren 300 mg | Drug | Aliskiren 300 mg tablet taken orally once a day with a glass of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) | After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors. | Baseline, End of Study (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) | After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors. |
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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 |
|---|---|---|---|---|---|---|
| Investigative site | Estonia | Estonia | ||||
| Investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22303910 | Derived | Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55. doi: 10.2174/157016112803520765. |
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This study consisted of a 7 day wash-out period and a 4 week single-blind run-in period prior to the 8 week double-blind period.
2 of the 820 randomized patients were randomized in error, are not included in the 818 participants enrolled in the double-blind period, did not receive study drug & are not included in the Safety and Full Analysis Sets.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren 300 mg/Amlodipine 10 mg | Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. |
| FG001 | Aliskiren 300 mg/Amlodipine 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aliskiren/Amlodipine 300/5 mg | Drug | Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. |
|
| Aliskiren/Amlodipine 300/10 mg | Drug | Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. |
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| Placebo to Aliskiren | Drug | Placebo to Aliskiren tablet taken orally once a day. |
|
| Placebo to Aliskiren/Amlodipine | Drug | Placebo to Aliskiren/Amlodipine taken orally once a day. |
|
| Baseline, End of Study (Week 8) |
| Number of Participants With Serious Adverse Events and Adverse Events | The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class. Additional information about Adverse Events can be found in the Adverse Event Section. | 8 weeks |
| Percentage of Participants Achieving Blood Pressure Control | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140. | 8 weeks |
| Percentage of Participants Achieving a Diastolic Blood Pressure Response | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline. | 8 weeks |
| Percentage of Participants Achieving a Systolic Blood Pressure Response | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline. | 8 weeks |
| France |
| France |
| Investigative Site | Iceland | Iceland |
| Investigative Site | India | India |
| Investigative site | Italy | Italy |
| Investigative Site | Lithuania | Lithuania |
| Investigative Site | Republic of Korea | South Korea |
| Investigative Site | Spain | Spain |
| Investigative Site | Venezuela | Venezuela |
Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
| FG002 | Aliskiren 300 mg | Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
| Safety & Full Analysis Sets |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren 300 mg/Amlodipine 10 mg | Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. |
| BG001 | Aliskiren 300 mg/Amlodipine 5 mg | Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. |
| BG002 | Aliskiren 300 mg | Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 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 From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) | After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors. | Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, End of Study (Week 8) |
|
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| Secondary | Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) | After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors. | Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, End of Study (Week 8) |
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| Secondary | Number of Participants With Serious Adverse Events and Adverse Events | The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class. Additional information about Adverse Events can be found in the Adverse Event Section. | Safety Population consisted of all randomized participants who received study drug. | Posted | Number | participants | 8 weeks |
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| Secondary | Percentage of Participants Achieving Blood Pressure Control | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140. | Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment. | Posted | Number | Percentage of participants | 8 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Diastolic Blood Pressure Response | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline. | Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment. | Posted | Number | Percentage of participants | 8 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Systolic Blood Pressure Response | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline. | Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment. | Posted | Number | Percentage of participants | 8 weeks |
|
8 weeks
Safety set (all patients who received at least 1 dose of double-blind study drug).
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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/Amlodipine 10 mg | Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. | 3 | 282 | 26 | 282 | ||
| EG001 | Aliskiren 300 mg/Amlodipine 5 mg | Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. | 4 | 276 | 6 | 276 | ||
| EG002 | Aliskiren 300 mg | Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. | 1 | 260 | 1 | 260 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General 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 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Aliskiren 300 mg |
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Aliskiren 300 mg |
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
|
|
| Aliskiren 300 mg |
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
|
|
| Aliskiren 300 mg |
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
|
|