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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132380 | Registry Identifier | JapicCTI | |
| JapicCTI-R171021 | Other Identifier | JapicCTI |
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The purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.
This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially available. The surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to ARB combination drugs, as well as changes in parameters such as blood pressure.
The usual adult dosage of Candesartan cilexetil is 4 to 8 mg, administered orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan Cilexetil tablets (2 to 12 mg) | Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan Cilexetil | Drug | Candesartan Cilexetil tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinic Blood Pressure in the Sitting Position | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported. | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported. | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions | Adverse drug reactions 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. |
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Inclusion Criteria:
Exclusion Criteria:
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Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan |
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Participants with a diagnosis of hypertension were enrolled to receive candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily for up to the last dose of study drug (up to Month 6).
Participants took part in the study at 1503 investigative sites in Japan, from 13-Jun-2011 to 25-Apr-2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan Cilexetil 4 mg to 8 mg | Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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 4 mg to 8 mg | Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. 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 | Changes in Clinic Blood Pressure in the Sitting Position | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported. | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was all participants in safety analysis set who were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) |
|
Up to Month 3
At each visit the investigator had to document any occurrence of adverse events 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 4 mg to 8 mg | Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA/J ver. 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system 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 |
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| Baseline and Last dose of ARB Combination Drug (up to Month 6) |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Baseline and Last dose of ARB Combination Drug (up to Month 6) |
| Up to Month 3 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Smoking Classification | 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. Participants may be represented in more than 1 category. | 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. Participants may be represented in more than 1 category. | Count of Participants | Participants |
|
| Initial Dose of Study Drug | Count of Participants | Participants |
|
| Concomitant Antihypertensive Drugs | Count of Participants | Participants |
|
| Switching Antihypertensive Drugs | Count of Participants | Participants |
|
| Status of Administration of Antihypertensive Drugs | Had no Antihypertensive Drugs; Participants who had not received concomitant antihypertensive drugs and switching antihypertensive drugs prior to the start of study drug were reported. Had Antihypertensive Drugs; Participants who had received concomitant antihypertensive drugs or switching antihypertensive drugs prior to the start of study drug were reported. | Count of Participants | Participants |
|
| Clinical Systolic Blood Pressure (SBP) (Sitting) | Mean | Standard Deviation | mmHg |
|
| Clinical Diastolic Blood Pressure (DBP) (Sitting) | Mean | Standard Deviation | mmHg |
|
| Early Morning Home SBP (Ave) | Mean | Standard Deviation | mmHg |
|
| Early Morning Home DBP (Ave) | Mean | Standard Deviation | mmHg |
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| Evening Home SBP (Ave) | Mean | Standard Deviation | mmHg |
|
| Evening Home DBP (Ave) | Mean | Standard Deviation | mmHg |
|
| Spot Urine Sodium: NaS | Mean | Standard Deviation | mEq/L |
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| Spot Urine Creatinine: CrS | Mean | Standard Deviation | mg/L |
|
| Estimated 24hr Creatinine Excretion: UCr24 | UCr24 = -2.04×age（years）＋14.89×weight（kg）＋16.14×height（cm）-2244.45 | Mean | Standard Deviation | mg/day |
|
| Estimated 24hr Sodium Excretion: UNa24 | UNa24 = 21.98×[(NaS/CrS) ×UCr24]^0.392 | Mean | Standard Deviation | mEq/day |
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| Salt Intake: NaCl24 | NaCl24 = UNa24×0.0585 | Mean | Standard Deviation | g/day |
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| Salt Intake: NaCl24 | NaCl24 = UNa24×0.0585 10 <= Spot Urine Sodium (mEq/L) < 500, 100 <= Spot Urine Creatinine (mg/L） < 5000 | Mean | Standard Deviation | g/day |
|
| Focus on Blood Pressure (BP) Measurement | Participants who were answered Home or Clinic for a question" Which blood pressure are you focusing on?" were reported. | Count of Participants | Participants |
|
|
|
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported. | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who continued candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) |
|
|
|
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) |
|
|
|
| Secondary | Number of Participants Who Experience at Least One Adverse Drug Reactions | Adverse drug reactions 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Count of Participants | Participants | Up to Month 3 |
|
|
|
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline and Last dose of ARB Combination Drug (up to Month 6) |
|
|
|
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline and Last dose of ARB Combination Drug (up to Month 6) |
|
|
|
| 36 |
| 17,130 |
| 41 |
| 17,130 |
| 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 |
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| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Papillary tumour of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Cervical myelopathy | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Binocular eye movement disorder | Eye disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Aortic aneurysm rupture | Vascular disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| 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. |
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| Pain | General disorders | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA/J ver. 16.0 | Systematic Assessment |
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| Prostatic operation | Surgical and medical procedures | MedDRA/J ver. 16.0 | Systematic Assessment |
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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.
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| Month 3, DBP |
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| Last Dose of Candesartan, DBP |
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| Last dose of ARB Combination Drug, SBP |
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| Month 3, DBP |
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| Last Dose of Candesartan, DBP |
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| Last dose of ARB Combination Drug, DBP |
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