Trial Outcomes & Findings for Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」 (NCT NCT02211638)

Last Updated: 2018-11-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

18113 participants

Primary outcome timeframe

Baseline, Month 3 and Last dose of Candesartan (up to Month 6)

Results posted on

2018-11-05

Participant Flow

Participants took part in the study at 1503 investigative sites in Japan, from 13-Jun-2011 to 25-Apr-2013.

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	18113
Overall Study COMPLETED	17130
Overall Study NOT COMPLETED	983

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Case Report Forms Uncollected	291
Overall Study Protocol Violation	692

Baseline Characteristics

Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Candesartan Cilexetil 4 mg to 8 mg n=17130 Participants 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.
Age, Continuous	65.9 Years STANDARD_DEVIATION 12.85 • n=5 Participants
Sex: Female, Male Female	8640 Participants n=5 Participants
Sex: Female, Male Male	8490 Participants n=5 Participants
Region of Enrollment Japan	17130 Participants n=5 Participants
Weight	61.3 kg STANDARD_DEVIATION 13.46 • n=5 Participants
Smoking Classification Never Smoked	11683 Participants n=5 Participants
Smoking Classification Current Smoker	2032 Participants n=5 Participants
Smoking Classification Unknown	3415 Participants n=5 Participants
Medical Complications Had no Medical Complications	7988 Participants n=5 Participants
Medical Complications Had Medical Complications	9142 Participants n=5 Participants
Medical History Had no Medical History	14376 Participants n=5 Participants
Medical History Had Medical History	2754 Participants n=5 Participants
Initial Dose of Study Drug 2mg/day	528 Participants n=5 Participants
Initial Dose of Study Drug 4mg/day	4865 Participants n=5 Participants
Initial Dose of Study Drug 8mg/day	11170 Participants n=5 Participants
Initial Dose of Study Drug 12mg/day	556 Participants n=5 Participants
Initial Dose of Study Drug Other Initial Dose	11 Participants n=5 Participants
Concomitant Antihypertensive Drugs Had no Concomitant Antihypertensive Drugs	11968 Participants n=5 Participants
Concomitant Antihypertensive Drugs Had Concomitant Antihypertensive Drugs	5162 Participants n=5 Participants
Switching Antihypertensive Drugs Had no Switching Antihypertensive Drugs	12856 Participants n=5 Participants
Switching Antihypertensive Drugs Had Switching Antihypertensive Drugs	4274 Participants n=5 Participants
Status of Administration of Antihypertensive Drugs Had no Antihypertensive Drugs	10055 Participants n=5 Participants
Status of Administration of Antihypertensive Drugs Had Antihypertensive Drugs	7075 Participants n=5 Participants
Clinical Systolic Blood Pressure (SBP) (Sitting)	156.1 mmHg STANDARD_DEVIATION 18.67 • n=5 Participants
Clinical Diastolic Blood Pressure (DBP) (Sitting)	88.7 mmHg STANDARD_DEVIATION 13.47 • n=5 Participants
Early Morning Home SBP (Ave)	153.9 mmHg STANDARD_DEVIATION 15.89 • n=5 Participants
Early Morning Home DBP (Ave)	89.4 mmHg STANDARD_DEVIATION 11.41 • n=5 Participants
Evening Home SBP (Ave)	146.2 mmHg STANDARD_DEVIATION 15.88 • n=5 Participants
Evening Home DBP (Ave)	85.5 mmHg STANDARD_DEVIATION 11.59 • n=5 Participants
Spot Urine Sodium: NaS	129.9 mEq/L STANDARD_DEVIATION 52.78 • n=5 Participants
Spot Urine Creatinine: CrS	804.2 mg/L STANDARD_DEVIATION 1002.82 • n=5 Participants
Estimated 24hr Creatinine Excretion: UCr24	1099.52 mg/day STANDARD_DEVIATION 349.732 • n=5 Participants
Estimated 24hr Sodium Excretion: UNa24	230.70 mEq/day STANDARD_DEVIATION 246.267 • n=5 Participants
Salt Intake: NaCl24	10.0 g/day STANDARD_DEVIATION 2.92 • n=5 Participants
Focus on Blood Pressure (BP) Measurement Focus on Home BP than Clinic BP	7614 Participants n=5 Participants
Focus on Blood Pressure (BP) Measurement Focus on Clinic BP than Home BP	8021 Participants n=5 Participants
Focus on Blood Pressure (BP) Measurement Other	1495 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil 4 mg to 8 mg n=16617 Participants 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.
Changes in Clinic Blood Pressure in the Sitting Position Month 3, SBP	-20.1 mmHg Standard Deviation 19.30
Changes in Clinic Blood Pressure in the Sitting Position Last Dose of Candesartan, SBP	-18.1 mmHg Standard Deviation 18.91
Changes in Clinic Blood Pressure in the Sitting Position Month 3, DBP	-10.4 mmHg Standard Deviation 12.34
Changes in Clinic Blood Pressure in the Sitting Position Last Dose of Candesartan, DBP	-9.3 mmHg Standard Deviation 12.12

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil 4 mg to 8 mg n=11753 Participants 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.
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
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil 4 mg to 8 mg n=3630 Participants 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.
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
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
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
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil 4 mg to 8 mg n=984 Participants 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.
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 20.20
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

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil 4 mg to 8 mg n=2666 Participants 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.
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
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

SECONDARY outcome

Timeframe: Up to Month 3

Population: Safety analysis set was defined as all participants who were enrolled and completed the study.

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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil 4 mg to 8 mg n=17130 Participants 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.
Number of Participants Who Experience at Least One Adverse Drug Reactions	132 Participants

Adverse Events

Candesartan Cilexetil 4 mg to 8 mg

Serious events: 36 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Candesartan Cilexetil 4 mg to 8 mg n=17130 participants at risk 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.
Infections and infestations Pneumonia	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary tumour of renal pelvis	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.01% 1/17130 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.01% 1/17130 • 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.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.01% 1/17130 • 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.
Metabolism and nutrition disorders Dehydration	0.01% 1/17130 • 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.
Nervous system disorders Cerebral infarction	0.01% 2/17130 • 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.
Nervous system disorders Cervical myelopathy	0.01% 1/17130 • 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.
Nervous system disorders Subarachnoid haemorrhage	0.01% 1/17130 • 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.
Nervous system disorders Lacunar infarction	0.01% 2/17130 • 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.
Eye disorders Binocular eye movement disorder	0.01% 1/17130 • 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.
Cardiac disorders Bradycardia	0.01% 2/17130 • 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.
Cardiac disorders Cardiac failure	0.01% 1/17130 • 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.
Cardiac disorders Cardiac failure chronic	0.01% 1/17130 • 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.
Cardiac disorders Cardiac tamponade	0.01% 1/17130 • 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.
Vascular disorders Aortic aneurysm rupture	0.01% 1/17130 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.01% 1/17130 • 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 1/17130 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.01% 1/17130 • 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.
Gastrointestinal disorders Abdominal pain	0.01% 1/17130 • 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.
Gastrointestinal disorders Constipation	0.01% 1/17130 • 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.
Gastrointestinal disorders Duodenal ulcer	0.01% 1/17130 • 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.
Gastrointestinal disorders Ileus	0.01% 1/17130 • 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.
Gastrointestinal disorders Intestinal obstruction	0.01% 1/17130 • 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.
Gastrointestinal disorders Vomiting	0.01% 1/17130 • 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.
Gastrointestinal disorders Mechanical ileus	0.01% 1/17130 • 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.
Hepatobiliary disorders Cholecystitis acute	0.01% 1/17130 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.01% 1/17130 • 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.
Renal and urinary disorders Urinary retention	0.01% 1/17130 • 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.
General disorders Death	0.01% 1/17130 • 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.
General disorders Pain	0.01% 1/17130 • 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.
Investigations Blood bilirubin increased	0.01% 1/17130 • 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.
Injury, poisoning and procedural complications Subdural haematoma	0.01% 1/17130 • 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.
Injury, poisoning and procedural complications Pelvic fracture	0.01% 1/17130 • 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.
Surgical and medical procedures Prostatic operation	0.01% 1/17130 • 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.

Other adverse events

Other adverse events
Measure	Candesartan Cilexetil 4 mg to 8 mg n=17130 participants at risk 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.
Nervous system disorders Dizziness	0.24% 41/17130 • 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.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER