At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy
In Brief
A Phase 4 clinical trial evaluating amlodipine and olmesartan medoxomil tablets and hydrochlorothiazide tablets for Hypertension. Completed, enrolled 999 participants across 72 sites.
Detailed Summary
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.
Study Details
Timeline
Interventions
amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks