Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
NCT ID: NCT00396656
Last Updated: 2011-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2005-12-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)
After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.
Atenolol
100 mg tablets orally once a day (od) in the morning.
Hydrochlorothiazide (HCTZ))
12.5 or 25 mg tablets orally once a day (od) in the morning.
Valsartan
80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan
After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.
After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.
Atenolol
100 mg tablets orally once a day (od) in the morning.
Hydrochlorothiazide (HCTZ))
12.5 or 25 mg tablets orally once a day (od) in the morning.
Valsartan
80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
Interventions
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Atenolol
100 mg tablets orally once a day (od) in the morning.
Hydrochlorothiazide (HCTZ))
12.5 or 25 mg tablets orally once a day (od) in the morning.
Valsartan
80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
Eligibility Criteria
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Inclusion Criteria
* At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and \< 110 mmHg.
Exclusion Criteria
* Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
* Known history of hypotensive symptoms or orthostatic hypotension.
* Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* A history of heart failure (NYHA II-IV).
40 Years
65 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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University Hospital Essen, Essen, Germany et al.
Principal Investigators
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Novartis Pharma Ag
Role: PRINCIPAL_INVESTIGATOR
Novartis Pharmaceuticals
Locations
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Investigative Centers, , Germany
Novartis Pharma Ag
Basel, , Switzerland
Countries
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Other Identifiers
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CVAH631BDE06
Identifier Type: -
Identifier Source: org_study_id
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