Hypertension
Conditions
Keywords
Drug therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGCandesartan cilexetil/Amlodipine besilate
Candesartan cilexetil/Amlodipine besilate tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1\. Participants with hypertension
Exclusion criteria
1. Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated \[Contraindications\] 2. Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations 3. Women who are pregnant or of child-bearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment | Baseline and final assessment (up to 12 Months) | Reported data are changes in SBP from baseline at final assessment (up to 12 months). |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment | Baseline and final assessment (up to 12 Months) | Reported data are changes in DBP from baseline at final assessment (up to 12 months). |
| Changes From Baseline in Pulse Rate at Final Assessment | Baseline and final assessment (up to 12 Months) | Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months). |
| Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment | Baseline and final assessment (up to 12 Months) | 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. |
Participant flow
Recruitment details
Participants took part in the study at 579 investigative sites in Japan, from 15 June 2010 to 31 May 2013.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 3,300 |
| Total | 3,300 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 60 |
| Overall Study | Protocol Deviation | 49 |
Baseline characteristics
| Characteristic | Candesartan Cilexetil/Amlodipine |
|---|---|
| Age, Continuous | 68.8 Years STANDARD_DEVIATION 12.2 |
| BMI | 24.14 kg/m^2 STANDARD_DEVIATION 3.83 |
| Drinking Habits Current Drinker | 942 Participants |
| Drinking Habits Ex-Drinker | 200 Participants |
| Drinking Habits Never Drank | 1707 Participants |
| Drinking Habits Unknown | 451 Participants |
| Duration of Hypertension | 6.29 Years STANDARD_DEVIATION 6.57 |
| Healthcare Category Inpatient | 8 Participants |
| Healthcare Category Outpatient | 3222 Participants 3.83 |
| Healthcare Category Outpatient and Inpatient | 70 Participants |
| History of Allergy Had No Presence of History of Allergy | 2872 Participants |
| History of Allergy Had Presence of History of Allergy | 222 Participants |
| History of Allergy Unknown | 206 Participants |
| Medical Complications Had No Presence of Medical Complications | 791 Participants |
| Medical Complications Had Presence of Medical Complications | 2509 Participants |
| Medical History Had No Presence of Medical History | 2567 Participants |
| Medical History Had Presence of Medial History | 630 Participants |
| Medical History Unknown | 103 Participants |
| Non Breast-Feeding Females | 1692 Participants |
| Region of Enrollment Japan | 3300 Participants |
| Sex: Female, Male Female | 1692 Participants |
| Sex: Female, Male Male | 1608 Participants |
| Smoking Classification Current Smoker | 402 Participants |
| Smoking Classification Ex-Smoker | 383 Participants |
| Smoking Classification Never Smoked | 2066 Participants |
| Smoking Classification Unknown | 449 Participants |
| Use of Antihypertensive Drug Prior to the Start of the Study Drug Had Not Used Antihypertensive Drug | 200 Participants |
| Use of Antihypertensive Drug Prior to the Start of the Study Drug Had Used Antihypertensive Drug | 3100 Participants |
| Waist Circumference | 86.47 centimeter (cm)] STANDARD_DEVIATION 9.85 |
| Weight | 60.43 kilograms (kg) STANDARD_DEVIATION 13.04 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 97 / 3,300 |
| serious Total, serious adverse events | 63 / 3,300 |
Outcome results
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.
Time frame: Up to 12 Months
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 85 Participants |
Primary
Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to 12 Months
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | Number of Participants Who Experience at Least One Adverse Events | 286 Participants |
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).
Time frame: Baseline and final assessment (up to 12 Months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Candesartan Cilexetil/Amlodipine | Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment | -7.2 mmHg | Standard Deviation 12.3 |
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).
Time frame: Baseline and final assessment (up to 12 Months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Candesartan Cilexetil/Amlodipine | Changes From Baseline in Pulse Rate at Final Assessment | -1.2 Beats per minute | Standard Deviation 10.2 |
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).
Time frame: Baseline and final assessment (up to 12 Months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Candesartan Cilexetil/Amlodipine | Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment | -14.6 mmHg | Standard Deviation 19.6 |
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.
Time frame: Baseline and final assessment (up to 12 Months)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candesartan Cilexetil/Amlodipine | Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment | Baseline | 28.5 Percentage of Participants |
| Candesartan Cilexetil/Amlodipine | Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment | Final Assessment | 66.9 Percentage of Participants |