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The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aggressive treatment regimen (5/320 mg to 10/320 mg) | Active Comparator | Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) |
|
| Moderate treatment regimen (5/160 mg) | Active Comparator | Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan and amlodipine | Drug |
| ||
| valsartan and amlodipine |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Weeks 2, 4, 8 and 12 | |
| Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline and Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Oparil, MD et al | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Egan Healthcare | Metairie | Louisiana | 70002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21045734 | Result | Oparil S, Giles T, Ofili EO, Pitt B, Seifu Y, Hilkert R, Samuel R, Sowers JR. Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. J Hypertens. 2011 Jan;29(1):161-70. doi: 10.1097/HJH.0b013e32834000a7. | |
| 21386706 | Derived |
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369 and 359 are the total randomized patients by treatment groups respectively. In the baseline measures tables 366 and 357 are the total patients for the ITT population by treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
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| Change From Baseline to Weeks 2, 8 and 12 in MSSBP | Baseline and Weeks 2, 8 and 12 |
| Change From Baseline to Weeks 2, 8 and 12 in MSDBP | Baseline and Weeks 2, 8 and 12 |
| Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 | Weeks 2, 4, 8 and 12 |
| Giles TD, Oparil S, Ofili EO, Pitt B, Purkayastha D, Hilkert R, Samuel R, Sowers JR. The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. Blood Press Monit. 2011 Apr;16(2):87-95. doi: 10.1097/MBP.0b013e328344c713. |
| FG001 | Moderate Treatment Regimen (5/160 mg) | Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) |
| BG001 | Moderate Treatment Regimen (5/160 mg) | Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) |
| 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, Customized | Number | participants |
| |||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| 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 From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Intent to treat (ITT), Last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 4 |
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| Secondary | Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Intent to treat (ITT), Last observation carried forward (LOCF) | Posted | Number | Percentage of Patients | Weeks 2, 4, 8 and 12 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) | Intent to treat (ITT), Last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 4 |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 2, 8 and 12 in MSSBP | Intent to treat (ITT), Last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | mmHg | Baseline and Weeks 2, 8 and 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 2, 8 and 12 in MSDBP | Intent to treat (ITT), Last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | mmHg | Baseline and Weeks 2, 8 and 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 | Intent to treat (ITT), Last observation carried forward (LOCF) | Posted | Number | Percentage of Patients | Weeks 2, 4, 8 and 12 |
|
|
12 weeks
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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 | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) | 4 | 369 | 50 | 369 | ||
| EG001 | Moderate Treatment Regimen (5/160 mg) | Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) | 10 | 359 | 29 | 359 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA | Systematic Assessment |
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| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Dizziness | 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 |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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 |
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| Title | Measurements |
|---|---|
|
| Male |
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| Change From Baseline to Week 4 in MSSBP |
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