NCT00791258

A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 999 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	amlodipine and olmesartan medoxomil tablets	amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
DRUG	hydrochlorothiazide tablets	hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2008-11-14
• Last updated: 2019-01-09
• Results posted: 2010-09-29

Locations

72 sites across 1 country: United States