NCT01289132

Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-536 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 926 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.

Detailed description

Hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. This becomes a medically and medical-economically significant problem in Japan The significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year. Takeda Pharmaceutical Company Limited invented TAK-536 (azilsartan), an angiotensin II receptor blocker for decreasing blood pressure. This study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo-matching tablets, orally, once daily for up to 12 weeks.
DRUG	Azilsartan	Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	Azilsartan	Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	Azilsartan	Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	Azilsartan	Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	Azilsartan	Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	Candesartan cilexetil	Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2011-02-03
• Last updated: 2011-02-03