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The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amlodipine/valsartan | Experimental | All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amlodipine/valsartan | Drug | Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Control rate of BP defined as BP lower than 140/90 mmHg at office visits | At week 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Change in systolic blood pressure measured in office from baseline at week 4 and 8. | baseline, week 4, week 8 |
| Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) | |||
| Novartis Investigative Site |
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One hundred thirty patients were screened and 115 were enrolled into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine/Valsartan | All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline population was the ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0)
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine/Valsartan | All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks. |
| 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 | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Control rate of BP defined as BP lower than 140/90 mmHg at office visits | The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values | Posted | Number | Percentage of Participants | At week 4 and 8 |
|
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The safety population included data from patients who attended Visit 2 which was 110 patients.
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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 | Amlodipine/Valsartan | amlodipine/valsartan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system 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 |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
| baseline, week 4, week 8 |
| Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day) | At week 4 and 8 |
| SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8. | At week 4 and 8 |
| Çanakkale |
| Turkey (Türkiye) |
| Novartis Investigative Site | Fatih / Istanbul | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Kinikli / Denizli | 20070 | Turkey (Türkiye) |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Malatya | 44280 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33079 | Turkey (Türkiye) |
| Novartis Investigative Site | Talas / Kayseri | 38039 | Turkey (Türkiye) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHG |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Heart rate | Mean | Standard Deviation | beats/min |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Change in systolic blood pressure measured in office from baseline at week 4 and 8. | The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values | Posted | Mean | Standard Deviation | mmHg | baseline, week 4, week 8 |
|
|
|
| Secondary | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Change in diastolic blood pressure measured in office from baseline at week 4 and week 8. | The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values | Posted | Mean | Standard Deviation | mmHg | baseline, week 4, week 8 |
|
|
|
| Secondary | Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day) | The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values | Posted | Number | Percentage of participants | At week 4 and 8 |
|
|
|
| Secondary | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8. | All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks. | Posted | Mean | Standard Deviation | mmHg | At week 4 and 8 |
|
|
|
| 3 |
| 110 |
| 76 |
| 110 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Diastolic dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left atrial dilatation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Urine sodium increased | Investigations | MedDRA | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Aortic aneurysm | Vascular 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 (ie, data from all sites) in the clinical trial
| D006571 |
| Heterocyclic Compounds |
| D017311 | Amlodipine |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| 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 |
|
| Systolic blood pressure (SBP) Week 8 LOCF (n=100) |
|
| Decrease in Systolic Week 4 (n=100) |
|
| Decrease in Systolic Week 8 (n=91) |
|
| Decrease in Systolic BP Week 8 LOCF (n=100) |
|
|
| Diastolic blood pressure (DBP) Week 8 LOCF (n=100) |
|
| Decrease in Diastolic BP Week 4 (n=100) |
|
| Decrease in Diastolic BP Week 8 (n=91) |
|
| Decrease in Diastolic BP Week 8 LOCF (n=100) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| DBP at Week 4 (n=70) |
|
| DBP at Week 8 (n=64) |
|
| DBP at Week 8 LOCF (n=70) |
|