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

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan cilexetil / hydrochlorothiazide

• Registration Number: NCT02016183
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-04-01
• Primary Completion: 2012-09-30
• Study Completion: 2012-09-30
• Study First Submitted: 2013-12-14
• Study First Submitted QC: 2013-12-14
• Study First Posted: 2013-12-19
• Results First Submitted: 2017-09-01
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Results First Posted: 2018-11-09
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3222

Inclusion Criteria

• Hypertensive patients

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Candesartan cilexetil / hydrochlorothiazide	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	Up to 12 months	ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point	Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)	Reported data are changes in SBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.
Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point	Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)	Reported data are changes in DBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.
Changes From Baseline in Pulse Rate at Each Time Point	Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)	Reported data are changes in Pulse Rate from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.