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The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan | Active Comparator | (patients initiated on valsartan) |
|
| HCTZ | Active Comparator | (patients initiated on HCTZ) |
|
| Valsartan + HCTZ | Experimental | (patients initiated on Valsartan+HCTZ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan + HCTZ | Drug | At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline and Weeks 4, 8, 12 and 16 | |
| Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline and Weeks 8, 12, and 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative site | Birmingham | Alabama | United States | |||
| Investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22520932 | Derived | Cushman WC, Duprez DA, Weintraub HS, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Home and clinic blood pressure responses in elderly individuals with systolic hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):210-8. doi: 10.1016/j.jash.2012.03.001. | |
| 22311004 | Derived | Weintraub HS, Duprez DA, Cushman WC, Zappe DH, Purkayastha D, Samuel R, Izzo JL Jr. Antihypertensive response to thiazide diuretic or angiotensin receptor blocker in elderly hypertensives is not influenced by pretreatment plasma renin activity. Cardiovasc Drugs Ther. 2012 Apr;26(2):145-55. doi: 10.1007/s10557-011-6365-x. |
| Label | URL |
|---|---|
| Click here for more information on the clinical study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valsartan | At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12 |
| FG001 | HCTZ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Valsartan | Drug | At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. |
|
| HCTZ | Drug | At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. |
|
| Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg | Cumulative refers to achieving of blood pressure control before or at the corresponding visit. | Weeks 4, 8, 12 and 16 |
| Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg) | Cumulative refers to achieving blood pressure goal before or at the corresponding visit. | Weeks 4, 8, 12 and 16 |
| Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg]) | During 16 weeks |
| Phoenix |
| Arizona |
| United States |
| Investigative Site | Escondido | California | United States |
| Investigative site | Fresno | California | United States |
| Investigative site | Huntington Park | California | United States |
| Investigative Sites | Pismo Beach | California | United States |
| Investigative site | Miami | Florida | United States |
| Investigative site | Ormond Beach | Florida | United States |
| Investigative site | Conyers | Georgia | United States |
| Investigative Site | Lexington | Kentucky | United States |
| Investigative site | Portland | Maine | United States |
| Investigative site | Las Vegas | Nevada | United States |
| Investigative site | Buffalo | New York | United States |
| Investigative site | Shelby | North Carolina | United States |
| Investigative site | Carlisle | Ohio | United States |
| Investigative site | Oklahoma City | Oklahoma | United States |
| Investigative site | Erie | Pennsylvania | United States |
| Investigative Site | Greer | South Carolina | United States |
| Investigative Site | Taylors | South Carolina | United States |
| Investigative site | St. George | Utah | United States |
| 21974759 | Derived | Izzo JL Jr, Weintraub HS, Duprez DA, Purkayastha D, Zappe D, Samuel R, Cushman WC. Treating systolic hypertension in the very elderly with valsartan-hydrochlorothiazide vs. either monotherapy: ValVET primary results. J Clin Hypertens (Greenwich). 2011 Oct;13(10):722-30. doi: 10.1111/j.1751-7176.2011.00498.x. Epub 2011 Jul 14. |
| 21747241 | Derived | Duprez DA, Weintraub HS, Cushman WC, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Effect of valsartan, hydrochlorothiazide, and their combination on 24-h ambulatory blood pressure response in elderly patients with systolic hypertension: a ValVET substudy. Blood Press Monit. 2011 Aug;16(4):186-96. doi: 10.1097/MBP.0b013e32834944e9. |
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. |
| FG002 | Valsartan + HCTZ | At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valsartan | At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12 |
| BG001 | HCTZ | At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. |
| BG002 | Valsartan + HCTZ | At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. |
| BG003 | 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 Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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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 Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) | Intent to treat (ITT), Last observation carried forward | Posted | Mean | Standard Deviation | mm Hg | Baseline and Week 4 |
|
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| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP) | Intent to treat (ITT), Last observation carried forward | Posted | Mean | Standard Deviation | mm Hg | Baseline and Weeks 4, 8, 12 and 16 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) | Intent to treat (ITT), Last observation carried forward | Posted | Mean | Standard Deviation | mm Hg | Baseline and Weeks 8, 12, and 16 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg | Cumulative refers to achieving of blood pressure control before or at the corresponding visit. | Intent to treat (ITT) | Posted | Number | Percentage of Participants | Weeks 4, 8, 12 and 16 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg) | Cumulative refers to achieving blood pressure goal before or at the corresponding visit. | Intent to treat (ITT) | Posted | Number | Percentage of Participants | Weeks 4, 8, 12 and 16 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg]) | Intent to treat (ITT) | Posted | Median | 95% Confidence Interval | Weeks | During 16 weeks |
|
|
16 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 | Valsartan + HCTZ | At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. | 3 | 128 | 16 | 128 | ||
| EG001 | HCTZ | At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. | 4 | 128 | 27 | 128 | ||
| EG002 | Valsartan | At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12 | 3 | 128 | 23 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | 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 |
| D006852 | Hydrochlorothiazide |
| 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 |
| 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 |
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| 76-80 years |
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| >80 years |
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| Male |
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| Change in MSSBP from Baseline to Week 4 |
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