N/A
Completed N=3,222
Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
Source: ClinicalTrials.gov NCT02016183 ↗Enrolled (actual)
3,222
Serious AEs
2.3%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) — 283 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) |
283 | — |
| SECONDARY Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point |
-13.3; -14.8; -15.4; -15.7; -15.6; -16.1 | — |
| SECONDARY Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point |
-6.5; -7.3; -7.6; -7.8; -7.8; -8.0 | — |
| SECONDARY Changes From Baseline in Pulse Rate at Each Time Point |
-1.3; -1.1; -1.3; -1.5; -1.3; -1.5 | — |
Eligibility 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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Data sourced from ClinicalTrials.gov (NCT02016183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.