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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132362 | Registry Identifier | JapicCTI |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil / hydrochlorothiazide | Drug | Candesartan cilexetil / hydrochlorothiazide combination tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | 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. | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point |
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Inclusion Criteria:
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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Patients with Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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Participants with a diagnosis of hypertension were enrolled to receive candesartan cilexetil/hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months as per routine medical practice.
Participants took part in the study at 557 investigative sites in Japan, from 01-Apr-2009 to 30-Sep-2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 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. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Count of Participants | Participants | Up to 12 months |
|
Up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Participants may be represented in more than 1 category.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | 1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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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. |
| Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) |
| Changes From Baseline in Pulse Rate at Each Time Point | 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. | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Number | Participants |
|
| Healthcare Category | Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient during some point at the time and 3 months prior to enrollment). | Count of Participants | Participants |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Smoking Classification | Count of Participants | Participants |
|
| Allergy/Predisposition to Hypersensitivity | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
|
| Duration of Disease | Mean | Standard Deviation | Years |
|
| Use of Antihypertensive Drug Prior to the Start of the Study Drug | Count of Participants | Participants |
|
| Violation of Inclusion or Exclusion Criteria | Count of Participants | Participants |
|
|
|
| Secondary | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) |
|
|
|
| Secondary | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) |
|
|
|
| Secondary | Changes From Baseline in Pulse Rate at Each Time Point | 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | Beats per minutes | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) |
|
|
|
| 72 |
| 3,157 |
| 158 |
| 3,157 |
| Pharyngitis | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Acute monocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Cerebral artery stenosis | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA/J ver. 16.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Oedema peripheral | General disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA/J ver. 16.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Blood creatinine increased | Investigations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA/J ver. 16.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
| Change in SBP at Month 3 |
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| Change in SBP at Month 4 |
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| Change in SBP at Month 5 |
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| Change in SBP at Month 6 |
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| Change in SBP at Month 7 |
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| Change in SBP at Month 8 |
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| Change in SBP at Month 9 |
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| Change in SBP at Month 10 |
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| Change in SBP at Month 11 |
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| Change in SBP at Month 12 |
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| Change in SBP at Final |
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| Change in DBP at Month 3 |
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| Change in DBP at Month 4 |
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| Change in DBP at Month 5 |
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| Change in DBP at Month 6 |
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| Change in DBP at Month 7 |
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| Change in DBP at Month 8 |
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| Change in DBP at Month 9 |
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| Change in DBP at Month 10 |
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| Change in DBP at Month 11 |
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| Change in DBP at Month 12 |
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| Change in DBP at Final |
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| Change in Pulse Rate at Month 3 |
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| Change in Pulse Rate at Month 4 |
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| Change in Pulse Rate at Month 5 |
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| Change in Pulse Rate at Month 6 |
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| Change in Pulse Rate at Month 7 |
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| Change in Pulse Rate at Month 8 |
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| Change in Pulse Rate at Month 9 |
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| Change in Pulse Rate at Month 10 |
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| Change in Pulse Rate at Month 11 |
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| Change in Pulse Rate at Month 12 |
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| Change in Pulse Rate at Final assessment |
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