Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
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|ClinicalTrials.gov Identifier: NCT02016183|
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
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|Condition or disease||Intervention/treatment|
|Hypertension||Drug: Candesartan cilexetil / hydrochlorothiazide|
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 Type :||Observational|
|Actual Enrollment :||3222 participants|
|Official Title:||ECARD Combination Tablets LD&HD Special Drug Use Surveillance: Long-term Use (12 Months)|
|Actual Study Start Date :||April 1, 2009|
|Actual Primary Completion Date :||September 30, 2012|
|Actual Study Completion Date :||September 30, 2012|
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.
Drug: Candesartan cilexetil / hydrochlorothiazide
Candesartan cilexetil / hydrochlorothiazide combination tablets
Other Name: ECARD® Combination Tablets LD&HD
- Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) [ Time Frame: 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.
- Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Hypertensive patients
(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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016183
|Study Director:||Study Director||Takeda|
|Other Study ID Numbers:||
JapicCTI-132362 ( Registry Identifier: JapicCTI )
|First Posted:||December 19, 2013 Key Record Dates|
|Results First Posted:||November 9, 2018|
|Last Update Posted:||November 9, 2018|
|Last Verified:||April 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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