Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
NCT ID: NCT00931710
Last Updated: 2011-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
488 participants
INTERVENTIONAL
2009-07-31
2010-01-31
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
DOUBLE
Study Groups
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Valsartan/amlodipine/HCTZ
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
valsartan, amlodipine, HCTZ
combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study
Losartan/HCTZ
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study
Interventions
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valsartan, amlodipine, HCTZ
combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study
Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study
Eligibility Criteria
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Inclusion Criteria
* Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and \< 200 mmHg at randomization
* Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.
Exclusion Criteria
* Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
* Refractory hypertension, defined as blood pressure \>140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
* Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.
18 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 Pharmaceuticals
Role: STUDY_DIRECTOR
862-778-8300
Locations
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sites in USA
East Hanover, New Jersey, United States
Countries
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Other Identifiers
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CVEA489AUS01
Identifier Type: -
Identifier Source: org_study_id
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