Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
NCT ID: NCT00529451
Last Updated: 2011-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1613 participants
INTERVENTIONAL
2007-09-30
2008-07-31
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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Aliskiren 300 mg
Aliskiren 300 mg once daily
Aliskiren
Aliskiren
Aliskiren 150 mg
Aliskiren 150 mg once daily
Aliskiren
Aliskiren
Aliskiren 75 mg
Aliskiren 75 mg once daily
Aliskiren
Aliskiren
Ramipril 5 mg
Ramipril 5 mg once daily
Ramipril
comparator
Interventions
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Aliskiren
Aliskiren
Ramipril
comparator
Eligibility Criteria
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Inclusion Criteria
* Patients must have msDBP \>OR= 95 mmHg and \< 110 mmHg at Visit 3
* Patients must have an absolute difference of \< or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3
Exclusion Criteria
* History or evidence of a secondary form of hypertension.
* History of transient ischemic cerebral attack within 12 months of visit 1.
* Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
* Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8% at Visit 1.
* Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: STUDY_CHAIR
Novartis
Locations
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Novartis Investigative Sites
China, , China
Novartis Investigative Sites
India, , India
Novartis Investigative Sites
Thailand, , Thailand
Countries
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References
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Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
Other Identifiers
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CSPP100A2339
Identifier Type: -
Identifier Source: org_study_id
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