Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-01

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD\&HD in hypertensive patients in the routine clinical setting

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Detailed Description

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This is a special drug use surveillance on long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD combination tablets) to evaluate in hypertensive patients in the routine clinical setting. Because the drug contains a diuretic (hydrochlorothiazide) , it is necessary to assess the safety, especially on serum uric acid. (the planned sample size is 3000).

The usual adult dosage is 1 tablet (4 mg/6.25 mg or 8 mg/6.25 mg as a candesartan cilexetil/hydrochlorothiazide) administered orally once daily. This drug should not be used as a first-line drug for hypertension treatment.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Candesartan cilexetil / hydrochlorothiazide

Candesartan cilexetil/Hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months. This drug should not be used as a first-line drug for hypertension treatment. Participants received interventions as part of routine medical care.

Candesartan cilexetil / hydrochlorothiazide

Intervention Type DRUG

Candesartan cilexetil / hydrochlorothiazide combination tablets

Interventions

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Candesartan cilexetil / hydrochlorothiazide

Candesartan cilexetil / hydrochlorothiazide combination tablets

Intervention Type DRUG

Other Intervention Names

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ECARD® Combination Tablets LD&HD

Eligibility Criteria

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Inclusion Criteria

* Hypertensive patients

Exclusion Criteria

(1) Patients with a history of hypersensitivity to ingredients of ECARD LD\&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) Patients with anuria or patients under hemodialysis (3) Patients with acute renal failure (4) Patients with noticeably decreased Na and K levels in body fluids (5) Pregnant women or women planning to become pregnant

\-

Eligible Sex

ALL

Accepts Healthy Volunteers

No