Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
NCT ID: NCT00219141
Last Updated: 2011-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2005-10-31
2007-11-30
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
DOUBLE
Study Groups
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Aliskiren 300 mg
Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.
Aliskiren 150/300 mg
Aliskiren 150 mg tablets
Aliskiren placebo
Aliskiren 150 mg placebo tablet
Losartan 50/100 mg placebo
Losartan 50/100 mg placebo capsules
Losartan 100 mg
Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.
Losartan 50/100 mg
Losartan 50 or 100 mg capsules
Aliskiren placebo
Aliskiren 150 mg placebo tablet
Aliskiren/losartan 300/100 mg
Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.
Aliskiren 150/300 mg
Aliskiren 150 mg tablets
Losartan 50/100 mg
Losartan 50 or 100 mg capsules
Aliskiren placebo
Aliskiren 150 mg placebo tablet
Interventions
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Aliskiren 150/300 mg
Aliskiren 150 mg tablets
Losartan 50/100 mg
Losartan 50 or 100 mg capsules
Aliskiren placebo
Aliskiren 150 mg placebo tablet
Losartan 50/100 mg placebo
Losartan 50/100 mg placebo capsules
Eligibility Criteria
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Inclusion Criteria
* Patients with a BMI \> 25 kg/m2
* Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO
Exclusion Criteria
* Patients treated with an ACE and ARB combination at study entry.
* Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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External Affairs
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Pharmaceuticals
East Hanover, New Jersey, United States
sites in Argentina
Argentina, , Argentina
sites in Colombia
Colombia, , Colombia
sites in Finland
Finland, , Finland
sites in Germany
Germany, , Germany
sites in Italy
Italy, , Italy
sites in Russia
Russia, , Russia
sites in Spain
Spain, , Spain
sites in Sweden
Sweden, , Sweden
Countries
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References
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Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.
Pouleur AC, Uno H, Prescott MF, Desai A, Appelbaum E, Lukashevich V, Smith BA, Dahlof B, Solomon SD; ALLAY Investigators. Suppression of aldosterone mediates regression of left ventricular hypertrophy in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2011 Dec;12(4):483-90. doi: 10.1177/1470320311414453. Epub 2011 Jul 11.
Other Identifiers
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CSPP100A2316
Identifier Type: -
Identifier Source: org_study_id
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