Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"

Takeda

Status: Completed

Conditions: Hypertension

Treatments: Drug: Azilsartan/Amlodipine

Study type: Observational

Funder types: Industry

Identifiers

NCT02181816

212-011

JapicCTI-142592 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) & High Dose (HD) (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.

Full description

This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.

For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.

Enrollment: 1,090 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

-Hypertensive patients

Exclusion criteria

-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:

1. Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
2. Patients who are pregnant or having possibilities of being pregnant
3. Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

Trial design

1,090 participants in 1 patient group

Azilsartan/Amlodipine

Description:

Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.

Treatment:

Drug: Azilsartan/Amlodipine