Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
NCT ID: NCT00446563
Last Updated: 2011-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2007-03-31
2010-03-31
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
NONE
Study Groups
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Amlodipine + Valsartan
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
Valsartan
160 mg film coated tablets taken orally once daily in the morning.
Amlodipine
5 mg or 10 mg tablets taken orally once daily in the morning.
Losartan + Hydrochlorothiazide
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
Hydrochlorothiazide
12.5 mg or 25 mg tablets taken orally once daily in the morning.
Losartan
100 mg tablets taken orally once daily in the morning.
Interventions
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Valsartan
160 mg film coated tablets taken orally once daily in the morning.
Amlodipine
5 mg or 10 mg tablets taken orally once daily in the morning.
Hydrochlorothiazide
12.5 mg or 25 mg tablets taken orally once daily in the morning.
Losartan
100 mg tablets taken orally once daily in the morning.
Eligibility Criteria
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Inclusion Criteria
* Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure \>=90 and \<= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of \>=90 and \<= 100mmHg.
* Patients with Left Ventricular Hypertrophy
Exclusion Criteria
* Symptomatic heart failure
* History of stroke, heart attack, coronary bypass surgery etc.
* Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.
18 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis
Role: STUDY_CHAIR
Novartis
Locations
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25 centers in Germany
Ludwigshafen, , Germany
Countries
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References
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Bruder O, Jensen CJ, Bell M, Rummel R, Boehm G, Klebs S, Sieder C, Senges J. Effects of the combinations of amlodipine/valsartan versus losartan/hydrochlorothiazide on left ventricular hypertrophy as determined with magnetic resonance imaging in patients with hypertension. J Drug Assess. 2011 Dec 16;1(1):1-10. doi: 10.3109/21556660.2011.639418. eCollection 2012.
Other Identifiers
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CVAA489ADE02
Identifier Type: -
Identifier Source: org_study_id
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