Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
NCT ID: NCT00797862
Last Updated: 2011-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1254 participants
INTERVENTIONAL
2008-11-30
2010-11-30
Brief Summary
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Detailed Description
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The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning.
The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Aliskiren + Amlodipine
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Aliskiren Start - Amlodipine Add-On
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Amlodipine Start- Aliskiren Add-On
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Interventions
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Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with essential hypertension:
* Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and \< 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.)
* All participants must have a msSBP ≥ 150 mmHg and \< 180 mmHg at Visit 2
* Written informed consent to participate in this study prior to any study procedures
Exclusion Criteria
* Pregnant or nursing (lactating) women
* Pre-menopausal women not taking accepted form of birth control
* Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
* History of cardiovascular conditions
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
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
Role: STUDY_CHAIR
Novartis
Locations
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Investigative Site
Toronto, , Canada
Investigative Site
San José, , Costa Rica
Investigative Site
Paris, , France
Investigative Site
Bonn, , Germany
Investigative Site
Athens, , Greece
Investigative Site
Guatemala City, , Guatemala
Investigative Site
Cape Town, , South Africa
Investigative Site
Basel, , Switzerland
Investigative Site
London, , United Kingdom
Investigative Site
Caracas, , Venezuela
Countries
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References
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Brown MJ, Williams B, Morant SV, Webb DJ, Caulfield MJ, Cruickshank JK, Ford I, McInnes G, Sever P, Salsbury J, Mackenzie IS, Padmanabhan S, MacDonald TM; British Hypertension Society's Prevention and Treatment of Hypertension with Algorithm-based Therapy (PATHWAY) Studies Group. Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial. Lancet Diabetes Endocrinol. 2016 Feb;4(2):136-47. doi: 10.1016/S2213-8587(15)00377-0. Epub 2015 Oct 18.
Brown MJ, McInnes GT, Papst CC, Zhang J, MacDonald TM. Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet. 2011 Jan 22;377(9762):312-20. doi: 10.1016/S0140-6736(10)62003-X. Epub 2011 Jan 12.
Other Identifiers
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CSPA100A2307
Identifier Type: -
Identifier Source: org_study_id