Conditions: Hypertension
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 328
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil versus placebo in Korean adults with essential hypertension.

Detailed description:
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat Korean adults with hypertension. This study will look at changes in blood pressure in people who take azilsartan medoxomil.

The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Azilsartan medoxomil 40 mg
* Azilsartan medoxomil 80 mg
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take two tablets at the same time each day throughout the study.

This multi-centre trial will be conducted in Korea. The overall time to participate in this study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Arms:
arm 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. arm 2: Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. arm 3: Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.

Interventions: intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil placebo
Intervention descriptions: intervention 1: Azilsartan medoxomil tablets intervention 2: Azilsartan medoxomil placebo-matching tablets

Protocol document: