Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren/Amlodipine | Experimental | Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg |
|
| Amlodipine | Active Comparator | Amlodipine 5mg titrated to 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren/Amlodipine | Drug | Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg). | Baseline, 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
Patients on 4 or more antihypertensive medications.
Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1
Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Evidence of a secondary form of hypertension, including but not limited to any of the following:
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of angioedema due to usage of an ARB or ACE inhibitor.
History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months
Other protocol defined inclusion/exclusion criteria applied
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Chicago | Illinois | United States | |||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21925996 | Derived | Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren/Amlodipine | Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg |
| FG001 | Amlodipine | Amlodipine 5mg titrated to 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Amlodipine | Drug | Amlodipine 5 mg titrated to 10mg |
|
| Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) |
Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted. |
| 8 weeks |
| Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) | Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted. | 8 weeks |
| Change From Baseline in MSSBP at Week 1 and 4 | Compare the change from baseline in MSSBP at week 1 and 4 | Baseline, 1 and 4 weeks |
| Percentage of Patients With Peripheral Edema by Visit | Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination. | 8 weeks |
| Baltimore |
| Maryland |
| United States |
| Investigative Site | Oxon Hill | Maryland | United States |
| Investigative Site | Detroit | Michigan | United States |
| Investigative Site | Trenton | New Jersey | United States |
| Investigative Site | Brooklyn | New York | United States |
| Investigative Site | Springfield Gardens | New York | United States |
| Investigative Site | Philadelphia | Pennsylvania | United States |
| Investigative Site | Milwaukeee | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren/Amlodipine | Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg |
| BG001 | Amlodipine | Amlodipine 5mg titrated to 10 mg |
| BG002 | 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| 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 in Mean Sitting Systolic Blood Pressure (msSBP) | To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension. | Full analysis set, Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | mm Hg | Baseline, 8 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg). | Full analysis set, Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | mm Hg | Baseline, 8 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) | Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted. | Full analysis set | Posted | Number | Percentage of participants | 8 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) | Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted. | Full analysis set | Posted | Number | Percentage of participants | 8 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MSSBP at Week 1 and 4 | Compare the change from baseline in MSSBP at week 1 and 4 | Full analysis set, Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | mm Hg | Baseline, 1 and 4 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Peripheral Edema by Visit | Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination. | Full Analysis Set | Posted | Number | Percentage of participants | 8 weeks |
|
|
8 weeks
Not provided
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 | Aliskiren/Amlodipine | Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg | 1 | 220 | 25 | 220 | ||
| EG001 | Amlodipine | Amlodipine 5mg titrated to 10 mg | 1 | 223 | 31 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system 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 |
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
| ≥55 years |
|
| Male |
|
|
|
|
|
|