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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181816
• Other study ID #: 212-011
• Secondary ID: JapicCTI-142592
• Status: Completed
• Start date: June 26, 2014
• Est. completion date: January 31, 2017

Study information

• Verified date: February 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Azilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets LD & HD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had One or More Adverse Events		Up to Month 12
Secondary	Systolic Office Blood Pressure	Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.	Baseline, Month 1, and final assessment point (up to Month 12)
Secondary	Diastolic Office Blood Pressure	Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.	Baseline, Month 1, and final assessment point (up to Month 12)