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The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valsartan/HCTZ | Experimental |
| |
| HCTZ +Amlodipine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCTZ + Amlodipine | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline to Weeks 4, 8, 12 and 16 | |
| Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg) | Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terence T. Hart, MD | Muscle Shoals | Alabama | 35662 | United States | ||
| Westlake Medical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22747613 | Derived | Deedwania PC, Zappe DH, Egan BM, Purkayastha D, Samuel R, Sowers JR. Does response of RAS blockade on serum K+ levels influence its glycemic-mitigating response when combined with hydrochlorothiazide? J Clin Hypertens (Greenwich). 2012 Jul;14(7):415-21. doi: 10.1111/j.1751-7176.2012.00635.x. Epub 2012 Apr 26. | |
| 22248871 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valsartan/HCTZ (Hydrochlorothiazide) | |
| FG001 | HCTZ +Amlodipine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Valsartan/HCTZ | Drug |
|
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| Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16) |
| Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg) | Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg | Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16) |
| Change From Baseline in Postprandial Glucose | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Week 16 |
| Change From Baseline in Postprandial Insulin | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Week 16 |
| Change From Baseline in Postprandial Non-esterified Fatty Acids | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Week 16 |
| Westlake Village |
| California |
| 91361 |
| United States |
| Oklahoma Cardiovascular & Hypertension | Oklahoma City | Oklahoma | 73132 | United States |
| Northeast Tarrant Internal Medicine Assoc | Euless | Texas | 76040 | United States |
| Frandsen Family Medicine | Port Orchard | Washington | 98366 | United States |
| Ofili EO, Zappe DH, Purkayastha D, Samuel R, Sowers JR. Antihypertensive and metabolic effects of Angiotensin receptor blocker/diuretic combination therapy in obese, hypertensive African American and white patients. Am J Ther. 2013 Jan;20(1):2-12. doi: 10.1097/MJT.0b013e318230ae66. |
| 20498618 | Derived | Sowers JR, Raij L, Jialal I, Egan BM, Ofili EO, Samuel R, Zappe DH, Purkayastha D, Deedwania PC. Angiotensin receptor blocker/diuretic combination preserves insulin responses in obese hypertensives. J Hypertens. 2010 Aug;28(8):1761-9. doi: 10.1097/HJH.0b013e32833af380. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valsartan/HCTZ (Hydrochlorothiazide) | |
| BG001 | HCTZ +Amlodipine | |
| BG002 | 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, Customized | Number | participants |
| |||||||||||||||||
| 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 Systolic Blood Pressure (MSSBP) | Intent to Treat (ITT), Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | mm Hg | Baseline to Week 8 |
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) | Intent to Treat (ITT), Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | mm Hg | Baseline to Weeks 4, 8, 12 and 16 |
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| Secondary | Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg) | Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg | Intent to Treat (ITT) | Posted | Number | participants | Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16) |
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| Secondary | Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg) | Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg | Intent to Treat (ITT) | Posted | Number | participants | Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16) |
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| Secondary | Change From Baseline in Postprandial Glucose | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Only those patients who completed the study through week 16 were included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Postprandial Insulin | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Only those patients who completed the study through week 16 were included in this analysis | Posted | Mean | Standard Deviation | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Postprandial Non-esterified Fatty Acids | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Only those patients who completed the study through week 16 were included in this analysis | Posted | Mean | Standard Deviation | mg/dL | Week 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1-862-778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| 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 |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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| Change from baseline |
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