Status:
COMPLETED
Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antih...
Detailed Description
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patient...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Core Study:
- \- Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and \< 110 mmHg
- Inclusion criteria for the Extension:
- \- msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study
- Exclusion Criteria for Core Study:
- Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood pressure ≥ 180 mmHg
- Patients with prior stroke, hypertensive encephalopathy or heart attack
- Patients with type 1 diabetes mellitus
- Patients with type 2 diabetes mellitus with poor glucose control
- Exclusion criteria for the Extension:
- Premature discontinuation in the core study or failure to comply with the core study protocol
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the SmPC (particularly amlodipine 5 mg), e.g. severe hypotension, shock - including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
- Any patient that the investigator decides should not participate in the extension study for medical reasons
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00867490
Start Date
March 1 2009
End Date
August 1 2009
Last Update
May 6 2011
Active Locations (1)
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1
Investigative Site
Chemnitz, Germany