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This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan+HCTZ - Phase 1 | Drug | 4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study | 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 patient in a sitting position for at least 5 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. | Baseline Phase 2 to end of Phase 2 |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study | 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 patient in a sitting position for at least 5 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. | Baseline Phase 3 to end of Phase 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study | 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 patient in a sitting position for at least 5 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. |
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Inclusion Criteria for Core Study:
- Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg
Inclusion criteria for the Extension:
- msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study
Exclusion Criteria for Core Study:
Exclusion criteria for the Extension:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Chemnitz | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21117946 | Derived | Schweizer J, Ulmer HJ, Benduhn H, Klebs S. Efficacy and tolerability of aliskiren 300 mg/hydrochlorothiazide 25 mg (+/- amlodipine 5 mg) in hypertensive patients not controlled by candesartan 32 mg plus HCT 25 mg. Curr Med Res Opin. 2011 Jan;27(1):131-40. doi: 10.1185/03007995.2010.537318. Epub 2010 Nov 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine | 4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 - Candesartan+HCTZ |
|
| ||||||||||||||||||||||||
| Phase 2 - Aliskiren+HCTZ |
| |||||||||||||||||||||||||
| Phase 3 - Aliskiren+HCTZ+Amlodipine |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine | 4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2. |
| 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 in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study | 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 patient in a sitting position for at least 5 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. | Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 2 to end of Phase 2 |
|
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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 | Phase 1 - Candesartan+HCTZ | 4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide (HCTZ) 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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The Phases of this study were entered in separate tables for outcomes and the Phases for SAEs and the AEs were entered all in one table.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| Aliskiren+HCTZ - Phase 2 | Drug | Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am. |
|
| Aliskiren+HCTZ+amlodipine - Phase 3 | Drug | The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am. |
|
| Baseline Phase 2 to end of Phase 2 |
| Change in Sitting Pulse Pressure During the Core Phase of the Study | Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs 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 patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. | Baseline Phase 2 to end of Phase 2 |
| Change in Sitting Pulse Rate During the Core Phase of the Study | Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. | Baseline Phase 2 to end of Phase 2 |
| Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study | Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. | Baseline Phase 2 to end of Phase 2 |
| Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study | Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. | Baseline Phase 2 to end of Phase 2 |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study | 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 patient in a sitting position for at least 5 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. | Baseline Phase 3 to end of Phase 3 |
| Change in Sitting Pulse Pressure During the Extension Phase of the Study | Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs 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 patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. | Baseline Phase 3 to end of Phase 3 |
| Change in Sitting Pulse Rate During the Extension Phase of the Study | Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. | Baseline Phase 3 to end of Phase 3 |
| Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study | Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg. | Baseline Phase 3 to end of Phase 3 |
| Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study | Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. | Baseline Phase 3 to end of Phase 3 |
|
| years |
|
| Sex/Gender, Customized | Female | Number | Participants |
|
| Sex/Gender, Customized | Male | Number | Participants |
|
| OG000 |
| Phase 2 - Aliskiren+HCTZ |
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am. |
|
|
| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study | 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 patient in a sitting position for at least 5 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. | Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 2 to end of Phase 2 |
|
|
|
| Secondary | Change in Sitting Pulse Pressure During the Core Phase of the Study | Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs 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 patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. | Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 2 to end of Phase 2 |
|
|
|
| Secondary | Change in Sitting Pulse Rate During the Core Phase of the Study | Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. | Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis. | Posted | Mean | 95% Confidence Interval | BPM (beats per minute) | Baseline Phase 2 to end of Phase 2 |
|
|
|
| Secondary | Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study | Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. | Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis. | Posted | Number | Percentage of patients | Baseline Phase 2 to end of Phase 2 |
|
|
|
| Secondary | Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study | Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. | Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis. | Posted | Number | Percentage of patients | Baseline Phase 2 to end of Phase 2 |
|
|
|
| Primary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study | 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 patient in a sitting position for at least 5 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. | Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 3 to end of Phase 3 |
|
|
|
| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study | 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 patient in a sitting position for at least 5 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. | Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 3 to end of Phase 3 |
|
|
|
| Secondary | Change in Sitting Pulse Pressure During the Extension Phase of the Study | Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs 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 patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. | Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 3 to end of Phase 3 |
|
|
|
| Secondary | Change in Sitting Pulse Rate During the Extension Phase of the Study | Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. | Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg. | Posted | Mean | 95% Confidence Interval | BPM (beats per minute) | Baseline Phase 3 to end of Phase 3 |
|
|
|
| Secondary | Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study | Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg. | Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg. | Posted | Number | Percentage of patients | Baseline Phase 3 to end of Phase 3 |
|
|
|
| Secondary | Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study | Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. | Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg. | Posted | Number | Percentage of patients | Baseline Phase 3 to end of Phase 3 |
|
|
|
| 1 |
| 186 |
| 0 |
| 186 |
| EG001 | Phase 2 - Aliskiren+HCTZ | Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am. | 2 | 123 | 0 | 123 |
| EG002 | Phase 3 - Aliskiren+HCTZ+Amlodipine | The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am. | 0 | 61 | 0 | 61 |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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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.