This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
847
Amlodipine 10 mg
Aliskiren/Amlodipine 150/10 mg
Aliskiren/Amlodipine 300/10 mg
Investigative Site
Buenos Aires, Argentina
Investigative Site
Berlin, Germany
Investigative Site
Oslo, Norway
Investigative Site
Warsaw, Poland
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Time frame: Baseline and Week 8
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
Time frame: Baseline and Week 8
Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
Time frame: 8 weeks
Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)
Time frame: 12 weeks
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Investigative Site
Bratislava, Slovakia
Investigative Site
Stockholm, Sweden
Investigative Site
Ankara, Turkey (Türkiye)