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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132390 | Registry Identifier | JapicCTI |
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The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.
This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine clinical setting.
The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine besilate) administered orally once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan cilexetil/Amlodipine besilate | 8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil/Amlodipine besilate | Drug | Candesartan cilexetil/Amlodipine besilate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Events | Up to 12 Months | |
| 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 Final Assessment | Reported data are changes in SBP from baseline at final assessment (up to 12 months). | Baseline and final assessment (up to 12 Months) |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment |
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Inclusion Criteria:
1. Participants with hypertension
Exclusion Criteria:
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Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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Participants with a historical diagnosis of hypertension were enrolled to receive Candesartan cilexetil/Amlodipine 8 milligram (mg)/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months.
Participants took part in the study at 579 investigative sites in Japan, from 15 June 2010 to 31 May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan Cilexetil/Amlodipine | Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. 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/Amlodipine | Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. 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 Events | 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/Amlodipine | Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 16.1 | 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 |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Reported data are changes in DBP from baseline at final assessment (up to 12 months). |
| Baseline and final assessment (up to 12 Months) |
| Changes From Baseline in Pulse Rate at Final Assessment | Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months). | Baseline and final assessment (up to 12 Months) |
| Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment | Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg. | Baseline and final assessment (up to 12 Months) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Duration of Hypertension | Mean Duration between start of study and first time of diagnosis of hypertension was reported. | Mean | Standard Deviation | Years |
|
| Healthcare Category | Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient throughout study). | Count of Participants | Participants |
|
| Non Breast-Feeding Females | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
| History of Allergy | 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 | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | centimeter (cm)] |
|
| Drinking Habits | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Use of Antihypertensive Drug Prior to the Start of the Study Drug | Count of Participants | Participants |
|
|
| 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 |
|
|
|
| Secondary | Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment | Reported data are changes in SBP from baseline at final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | mmHg | Baseline and final assessment (up to 12 Months) |
|
|
|
| Secondary | Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment | Reported data are changes in DBP from baseline at final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | mmHg | Baseline and final assessment (up to 12 Months) |
|
|
|
| Secondary | Changes From Baseline in Pulse Rate at Final Assessment | Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | Beats per minute | Baseline and final assessment (up to 12 Months) |
|
|
|
| Secondary | Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment | Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given time point. | Posted | Number | Percentage of Participants | Baseline and final assessment (up to 12 Months) |
|
|
|
| 63 |
| 3,300 |
| 97 |
| 3,300 |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Motor neurone disease | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial ischaemial | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | 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.