Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Candesartan+HCTZ - Phase 1 (Drug); Aliskiren+HCTZ - Phase 2 (Drug); Aliskiren+HCTZ+amlodipine - Phase 3 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Study Director, Affiliation: Novartis
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 antihypertensive medication. There was an optional study extension for the first
eligible 60 patients who wanted to participate that contains the triple therapy with
amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.
Clinical Details
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the StudyChange in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
Secondary outcome: Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the StudyChange in Sitting Pulse Pressure During the Core Phase of the Study Change in Sitting Pulse Rate During the Core Phase of the Study Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study Change in Sitting Pulse Pressure During the Extension Phase of the Study Change in Sitting Pulse Rate During the Extension Phase of the Study Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
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 patients not adequately responding to a 4 week therapy each with the
combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg
plus hydrochlorothiazide 25 mg
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Investigative Site, Chemnitz, Germany
Additional Information
Starting date: March 2009
Last updated: May 4, 2011
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