Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
NCT ID: NCT00698646
Last Updated: 2011-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
384 participants
INTERVENTIONAL
2008-04-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Valsartan
(patients initiated on valsartan)
Valsartan
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
(patients initiated on HCTZ)
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.
Valsartan + HCTZ
(patients initiated on Valsartan+HCTZ)
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.
Interventions
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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.
Valsartan
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
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with hypertension prior to being randomized into study.
* Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
* Have the ability to communicate and comply with all study requirements.
* Provide written informed consent to participate in the study prior to any screening or study procedures.
Exclusion Criteria
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
* Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Locations
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Investigative site
Birmingham, Alabama, United States
Investigative site
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
Countries
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References
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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.
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.
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.
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.
Related Links
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Other Identifiers
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CVAH631BUS08
Identifier Type: -
Identifier Source: org_study_id
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