Hypertension Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects With Essential Hypertension Who Are Inadequately Controlled on 16 mg Candesartan Cilexetil Monotherapy
This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106
(nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate
control of blood pressure with candesartane alone.
Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five
weeks of the study to assess blood pressure control with candesartan given alone.
Patients with an insufficient therapeutic response to candesartan alone (defined by mean
seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will
be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine
/ candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor
the treating physician will know which treatment is given (double-blinded design).This part
of the study will last eight weeks.
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