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This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan/amlodipine 80/5 mg | Experimental |
| |
| Valsartan 80 mg | Active Comparator |
| |
| Valsartan 160 mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan/amlodipine 80/5 mg | Drug | 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Baseline to end of study (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences | Beijing | 100020 | China | |||
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A total of 1134 patients were enrolled into the single-blind period of the study, and 216 (19%) were discontinued. In total, 918 patients were randomized to the three treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Valsartan/Amlodipine 80/5 mg | 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily |
| FG001 | Valsartan 80 mg | 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Single-Blind |
|
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| Valsartan 80 mg | Drug | 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily |
|
| Valsartan 160 mg | Drug | 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily |
|
| Baseline to end of study (Week 8) |
| Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Baseline to end of study (Week 8) |
| Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) | Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | End of study (Week 8) |
| Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | End of study (Week 8) |
| Beijing General Hospital of Beijing Military Region |
| Beijing |
| 100700 |
| China |
| Beijing Hospital | Beijing | 100730 | China |
| The First People's Hospital of Hangzhou | Hangzhou | 310006 | China |
| The Second Affiliated Hospital of Medical College of Zhejiang University | Hangzhou | 310006 | China |
| The First Affiliated Hospital of Medical College of Zhejiang University | Hangzhou | 310007 | China |
| Southeast University Affiliated Zhong Da Hospital | Nanjing | 210009 | China |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | 210029 | China |
| Second Military Medical University Affiliated Changzheng Hospital | Shanghai | 200003 | China |
| Department of cardiology, Ruijin hospital; | Shanghai | 200025 | China |
| Department of cardiology, Ruijin hospital | Shanghai | 200025 | China |
| Fudan University affiliated zhongshan hospital | Shanghai | 200032 | China |
| Second Military Medical University Affiliated Changhai Hospital | Shanghai | 200433 | China |
| The First Affiliated Hospital of China Medical University | Shenyang | 110001 | China |
| The people's Hospital of Liaoning Province | Shenyang | 110016 | China |
| Second Hospital of Hebei University of Medical Sciences | Shijiazhuang | 050050 | China |
| The People's Hospital of Hebei Provincial | Shijiazhuang | 050051 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | 215004 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | 215006 | China |
| FG002 | Valsartan 160 mg | 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily |
| COMPLETED |
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| NOT COMPLETED |
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| Double-Blind |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valsartan/Amlodipine 80/5 mg | 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily |
| BG001 | Valsartan 80 mg | 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily |
| BG002 | Valsartan 160 mg | 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | All baseline measures were based on Full-set analysis population. Two patients were excluded from the full-set analysis population for having no post-baseline efficacy assessment. All randomized patients were included in the safety population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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) From Baseline to End of Study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to end of study (Week 8) |
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| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to end of study (Week 8) |
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| Secondary | Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Posted | Number | Percentage of patients | Baseline to end of study (Week 8) |
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| Secondary | Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) | Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Posted | Number | Percentage of patients | End of study (Week 8) |
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| Secondary | Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Posted | Number | Percentage of patients | End of study (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 | Valsartan/Amlodipine 80/5 mg | 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily | 4 | 308 | 0 | 308 | ||
| EG001 | Valsartan 80 mg | 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily | 0 | 307 | 0 | 307 | ||
| EG002 | Valsartan 160 mg | 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily | 4 | 303 | 0 | 303 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
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| Abdominal injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
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| Transient ischaemic attack | Nervous system 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.
| 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 |
|---|---|
| D000068756 | Valsartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
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| Protocol deviation |
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| Subject withdrew consent |
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| Lost to Follow-up |
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| Male |
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1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
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1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
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