Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

Takeda

Status: Completed

Conditions: Hypertension

Treatments: Drug: Candesartan cilexetil/Amlodipine besilate

Study type: Observational

Funder types: Industry

Identifiers

NCT02068495

119-011

JapicCTI-132390 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.

Full description

This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine clinical setting.

The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine besilate) administered orally once daily.

Enrollment: 3,409 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with hypertension

Exclusion criteria

1. Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated [Contraindications]
2. Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations
3. Women who are pregnant or of child-bearing potential

Trial design

3,409 participants in 1 patient group

Candesartan cilexetil/Amlodipine besilate

Description:

8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily

Treatment:

Drug: Candesartan cilexetil/Amlodipine besilate