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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

926 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Azilsartan in Subjects With Essential Hypertension

NCT00759551

Hypertension

COMPLETED PHASE2

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

NCT00362115

Hypertension

COMPLETED PHASE2

A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

NCT00696384

Hypertension

COMPLETED PHASE3

Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension

NCT00696241

Hypertension

COMPLETED PHASE3

Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension

NCT00591773

Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo-matching tablets, orally, once daily for up to 12 weeks.

Azilsartan 5 mg QD

Group Type EXPERIMENTAL

Azilsartan

Intervention Type DRUG

Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.

Azilsartan 10 mg QD

Group Type EXPERIMENTAL

Azilsartan

Intervention Type DRUG

Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.

Azilsartan 20 mg QD

Group Type EXPERIMENTAL

Azilsartan

Intervention Type DRUG

Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.

Azilsartan 40 mg QD

Group Type EXPERIMENTAL

Azilsartan

Intervention Type DRUG

Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.

Azilsartan 80 mg QD

Group Type EXPERIMENTAL

Azilsartan

Intervention Type DRUG

Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.

Candesartan Cilexetil 8 mg titrated to12 mg QD

Group Type ACTIVE_COMPARATOR

Candesartan cilexetil

Intervention Type DRUG

Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo-matching tablets, orally, once daily for up to 12 weeks.

Intervention Type DRUG

Azilsartan

Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type DRUG

Azilsartan

Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type DRUG

Azilsartan

Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type DRUG

Azilsartan

Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type DRUG

Azilsartan

Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TAK-536 TAK-536 TAK-536 TAK-536 TAK-536 Blopress® TCV-116

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Has mild to moderate uncomplicated essential hypertension.
* Has a sitting diastolic blood pressure between 95 and \<110 mmHg and sitting systolic blood pressure between 150 and \<180 mmHg at placebo run-in period (Week -2) or randomization visit.

Exclusion Criteria

* Has a cardiovascular disease or symptoms
* Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.
* Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No