Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Candesartan+HCTZ - Phase 1; Aliskiren+HCTZ - Phase 2; Aliskiren+HCTZ+amlodipine - Phase 3
Intervention description: 4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.; Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.; The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; aliskiren; cardiovascular diseases

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.
    

Eligibility 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.