Hypertension
Conditions
Keywords
Drug Therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGCandesartan Cilexetil
Candesartan Cilexetil tablet
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Hypertensive patients
Exclusion criteria
1. Inpatients 2. Patients under dialysis (planned) 3. Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months 4. Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure 5. Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past 6. Patients who are pregnant or may possibly become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Clinic Blood Pressure in the Sitting Position | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | 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. |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | 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. |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) | 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. |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | Baseline and Last dose of ARB Combination Drug (up to Month 6) | 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. |
| 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 | Baseline and Last dose of ARB Combination Drug (up to Month 6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions | Up to Month 3 | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1503 investigative sites in Japan, from 13-Jun-2011 to 25-Apr-2013.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 17,130 |
| Total | 17,130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 291 |
| Overall Study | Protocol Violation | 692 |
Baseline characteristics
| Characteristic | Candesartan Cilexetil 4 mg to 8 mg |
|---|---|
| Age, Continuous | 65.9 Years STANDARD_DEVIATION 12.85 |
| Clinical Diastolic Blood Pressure (DBP) (Sitting) | 88.7 mmHg STANDARD_DEVIATION 13.47 |
| Clinical Systolic Blood Pressure (SBP) (Sitting) | 156.1 mmHg STANDARD_DEVIATION 18.67 |
| Concomitant Antihypertensive Drugs Had Concomitant Antihypertensive Drugs | 5162 Participants |
| Concomitant Antihypertensive Drugs Had no Concomitant Antihypertensive Drugs | 11968 Participants |
| Early Morning Home DBP (Ave) | 89.4 mmHg STANDARD_DEVIATION 11.41 |
| Early Morning Home SBP (Ave) | 153.9 mmHg STANDARD_DEVIATION 15.89 |
| Estimated 24hr Creatinine Excretion: UCr24 | 1099.52 mg/day STANDARD_DEVIATION 349.732 |
| Estimated 24hr Sodium Excretion: UNa24 | 230.70 mEq/day STANDARD_DEVIATION 246.267 |
| Evening Home DBP (Ave) | 85.5 mmHg STANDARD_DEVIATION 11.59 |
| Evening Home SBP (Ave) | 146.2 mmHg STANDARD_DEVIATION 15.88 |
| Focus on Blood Pressure (BP) Measurement Focus on Clinic BP than Home BP | 8021 Participants |
| Focus on Blood Pressure (BP) Measurement Focus on Home BP than Clinic BP | 7614 Participants |
| Focus on Blood Pressure (BP) Measurement Other | 1495 Participants |
| Initial Dose of Study Drug 12mg/day | 556 Participants |
| Initial Dose of Study Drug 2mg/day | 528 Participants |
| Initial Dose of Study Drug 4mg/day | 4865 Participants |
| Initial Dose of Study Drug 8mg/day | 11170 Participants |
| Initial Dose of Study Drug Other Initial Dose | 11 Participants |
| Medical Complications Had Medical Complications | 9142 Participants |
| Medical Complications Had no Medical Complications | 7988 Participants |
| Medical History Had Medical History | 2754 Participants |
| Medical History Had no Medical History | 14376 Participants |
| Region of Enrollment Japan | 17130 Participants |
| Salt Intake: NaCl24 | 10.0 g/day STANDARD_DEVIATION 2.92 |
| Sex: Female, Male Female | 8640 Participants |
| Sex: Female, Male Male | 8490 Participants |
| Smoking Classification Current Smoker | 2032 Participants |
| Smoking Classification Never Smoked | 11683 Participants |
| Smoking Classification Unknown | 3415 Participants |
| Spot Urine Creatinine: CrS | 804.2 mg/L STANDARD_DEVIATION 1002.82 |
| Spot Urine Sodium: NaS | 129.9 mEq/L STANDARD_DEVIATION 52.78 |
| Status of Administration of Antihypertensive Drugs Had Antihypertensive Drugs | 7075 Participants |
| Status of Administration of Antihypertensive Drugs Had no Antihypertensive Drugs | 10055 Participants |
| Switching Antihypertensive Drugs Had no Switching Antihypertensive Drugs | 12856 Participants |
| Switching Antihypertensive Drugs Had Switching Antihypertensive Drugs | 4274 Participants |
| Weight | 61.3 kg STANDARD_DEVIATION 13.46 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 17,130 |
| serious Total, serious adverse events | 36 / 17,130 |
Outcome results
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.
Time frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position | Month 3, SBP | -20.1 mmHg | Standard Deviation 19.3 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position | Last Dose of Candesartan, SBP | -18.1 mmHg | Standard Deviation 18.91 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position | Month 3, DBP | -10.4 mmHg | Standard Deviation 12.34 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position | Last Dose of Candesartan, DBP | -9.3 mmHg | Standard Deviation 12.12 |
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.
Time frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Month 3, SBP | -19.8 mmHg | Standard Deviation 18.74 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Last Dose of Candesartan, SBP | -19.5 mmHg | Standard Deviation 18.64 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Month 3, DBP | -10.1 mmHg | Standard Deviation 12.01 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Last Dose of Candesartan, DBP | -10.0 mmHg | Standard Deviation 12.03 |
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.
Time frame: Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Month 3, SBP | -21.7 mmHg | Standard Deviation 20.74 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Last Dose of Candesartan, SBP | -12.3 mmHg | Standard Deviation 18.83 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Last dose of ARB Combination Drug, SBP | -26.4 mmHg | Standard Deviation 20.49 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Month 3, DBP | -11.8 mmHg | Standard Deviation 13.26 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Last Dose of Candesartan, DBP | -6.4 mmHg | Standard Deviation 12.04 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Last dose of ARB Combination Drug, DBP | -14.4 mmHg | Standard Deviation 13.45 |
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.
Time frame: Baseline and Last dose of ARB Combination Drug (up to Month 6)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Candesartan Cilexetil 4 mg to 8 mg | 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 | SBP | -26.9 mmHg | Standard Deviation 20.54 |
| Candesartan Cilexetil 4 mg to 8 mg | 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 | DBP | -14.7 mmHg | Standard Deviation 13.53 |
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.
Time frame: Baseline and Last dose of ARB Combination Drug (up to Month 6)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | SBP | -24.5 mmHg | Standard Deviation 20.2 |
| Candesartan Cilexetil 4 mg to 8 mg | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | DBP | -13.2 mmHg | Standard Deviation 13.62 |
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.
Time frame: Up to Month 3
Population: Safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Candesartan Cilexetil 4 mg to 8 mg | Number of Participants Who Experience at Least One Adverse Drug Reactions | 132 Participants |