Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Candesartan cilexetil / hydrochlorothiazide (Drug)
Phase: N/A
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Postmarketing Group Manager, Study Chair, Affiliation: Takeda
Summary
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
Clinical Details
Official title: ECARD Combination Tablets LD&HD Special Drug Use Surveillance: Long-term Use (12 Months)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Frequency of adverse drug reactions
Secondary outcome: Changes from baseline in blood pressure
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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Locations and Contacts
Additional Information
Starting date: April 2009
Last updated: December 14, 2013
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