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This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ | Experimental | During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only. |
|
| 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 (Week 4) to end of Phase 2 (Week 8) |
| 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 (Week 8) to end of Phase 3 (Week 12) |
| 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:
Inclusion Criteria for Extension:
- Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.
Exclusion Criteria for Core study:
Exclusion Criteria for Extension:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site, , Germany | Schwerin | Germany | ||||
| 30 sites in Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ | During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 - Amlodipine+Olmesartan |
|
| ||||||||||||||||||||||||
| Phase 2 - Amlodipine+Valsartan |
| |||||||||||||||||||||||||
| Phase 3 - Amlodipine+Valsartan+HCTZ |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ | During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. |
| 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 amlodipine plus valsartan 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 (Week 4) to end of Phase 2 (Week 8) |
|
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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 - Amlodipine+Olmesartan | 4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUDDEN HEARING LOSS | Ear and labyrinth 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 |
|---|---|
| D017311 | Amlodipine |
| D000068557 | Olmesartan Medoxomil |
| D000068838 | Amlodipine, Valsartan Drug Combination |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Olmesartan medoxomil | Drug | Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only. |
|
| Amlodipine+valsartan | Drug | Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase. |
|
|
| Hydrochlorothiazide | Drug | Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase. |
|
|
| Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) |
| 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 (Week 4) to end of Phase 2 (Week 8) |
| 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 (Week 4) to end of Phase 2 (Week 8) |
| 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 (Week 4) to end of Phase 2 (Week 8) |
| 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 (Week 8) compared to Baseline in Phase 2 (week 4) 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 of Phase 2 (Week 4) to end of Phase 2 (Week 8) |
| 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 (Week 8) to end of Phase 3 (Week 12) |
| 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 (Week 8) to end of Phase 3 (Week 12) |
| 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 (Week 8) to end of Phase 3 (week 12) |
| Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study | Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. | Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) |
| Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension 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 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3. | Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12) |
| Administrative problems |
|
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG000 | Amlodipine+Valsartan - Phase 2 | Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning. |
|
|
| 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 amlodipine plus valsartan 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 (Week 4) to end of Phase 2 (Week 8) |
|
|
|
| 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 amlodipine plus valsartan 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 (Week 4) to end of Phase 2 (Week 8) |
|
|
|
| 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 amlodipine plus valsartan 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 (Week 4) to end of Phase 2 (Week 8) |
|
|
|
| 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 amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) |
|
|
|
| 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 amlodipine plus valsartan 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 participants | Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) |
|
|
|
| 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 (Week 8) compared to Baseline in Phase 2 (week 4) 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 amlodipine plus valsartan 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 participants | Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8) |
|
|
|
| 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 amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) |
|
|
|
| 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 amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) |
|
|
|
| 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 amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg. | Posted | Mean | 95% Confidence Interval | BPM (beats per minute) | Baseline Phase 3 (Week 8) to end of Phase 3 (week 12) |
|
|
|
| Secondary | Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study | Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. | Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg. | Posted | Number | Percentage of participants | Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) |
|
|
|
| Secondary | Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension 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 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3. | Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg. | Posted | Number | Percentage of participants | Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12) |
|
|
|
| 1 |
| 257 |
| 0 |
| 257 |
| EG001 | Phase 2 - Amlodipine+Valsartan | Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning. | 0 | 176 | 0 | 176 |
| EG002 | Phase 3 - Amlodipine+Valsartan+HCTZ | Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning. | 0 | 91 | 0 | 91 |
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.
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
| D000068756 | Valsartan |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |