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

Takeda

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: Candesartan cilexetil; Drug: Placebo; Drug: Azilsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01289132

TAK-536/CCT-001

U1111-1118-3346 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 926 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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926 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Azilsartan 5 mg QD

Experimental group

Treatment:

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Azilsartan 10 mg QD

Experimental group

Treatment:

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Azilsartan 20 mg QD

Experimental group

Treatment:

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Azilsartan 40 mg QD

Experimental group

Treatment:

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Azilsartan 80 mg QD

Experimental group

Treatment:

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Drug: Azilsartan

Candesartan Cilexetil 8 mg titrated to12 mg QD

Active Comparator group

Treatment:

Drug: Candesartan cilexetil