Trial Outcomes & Findings for Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use" (NCT NCT02068495)

NCT ID: NCT02068495

Last Updated: 2018-07-26

Results Overview

Recruitment status

COMPLETED

Target enrollment

3409 participants

Primary outcome timeframe

Up to 12 Months

Results posted on

2018-07-26

Participant Flow

Participants took part in the study at 579 investigative sites in Japan, from 15 June 2010 to 31 May 2013.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3409
Overall Study COMPLETED	3300
Overall Study NOT COMPLETED	109

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Case Report Forms Uncollected	60
Overall Study Protocol Deviation	49

Baseline Characteristics

This baseline characteristic was analyzed only in female participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Candesartan Cilexetil/Amlodipine n=3300 Participants 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.
Age, Continuous	68.8 Years STANDARD_DEVIATION 12.2 • n=3300 Participants
Sex: Female, Male Female	1692 Participants n=3300 Participants
Sex: Female, Male Male	1608 Participants n=3300 Participants
Region of Enrollment Japan	3300 Participants n=3300 Participants
Duration of Hypertension	6.29 Years STANDARD_DEVIATION 6.57 • n=3300 Participants
Healthcare Category Outpatient	3222 Participants 3.83 • n=3300 Participants
Healthcare Category Inpatient	8 Participants n=3300 Participants
Healthcare Category Outpatient and Inpatient	70 Participants n=3300 Participants
Non Breast-Feeding Females	1692 Participants n=1692 Participants • This baseline characteristic was analyzed only in female participants.
History of Allergy Had No Presence of History of Allergy	2872 Participants n=3300 Participants
History of Allergy Had Presence of History of Allergy	222 Participants n=3300 Participants
History of Allergy Unknown	206 Participants n=3300 Participants
Medical Complications Had No Presence of Medical Complications	791 Participants n=3300 Participants
Medical Complications Had Presence of Medical Complications	2509 Participants n=3300 Participants
Medical History Had No Presence of Medical History	2567 Participants n=3300 Participants
Medical History Had Presence of Medial History	630 Participants n=3300 Participants
Medical History Unknown	103 Participants n=3300 Participants
Weight	60.43 kilograms (kg) STANDARD_DEVIATION 13.04 • n=3300 Participants
BMI	24.14 kg/m^2 STANDARD_DEVIATION 3.83 • n=3300 Participants
Waist Circumference	86.47 centimeter (cm)] STANDARD_DEVIATION 9.85 • n=3300 Participants
Drinking Habits Never Drank	1707 Participants n=3300 Participants
Drinking Habits Current Drinker	942 Participants n=3300 Participants
Drinking Habits Ex-Drinker	200 Participants n=3300 Participants
Drinking Habits Unknown	451 Participants n=3300 Participants
Smoking Classification Never Smoked	2066 Participants n=3300 Participants
Smoking Classification Current Smoker	402 Participants n=3300 Participants
Smoking Classification Ex-Smoker	383 Participants n=3300 Participants
Smoking Classification Unknown	449 Participants n=3300 Participants
Use of Antihypertensive Drug Prior to the Start of the Study Drug Had Not Used Antihypertensive Drug	200 Participants n=3300 Participants
Use of Antihypertensive Drug Prior to the Start of the Study Drug Had Used Antihypertensive Drug	3100 Participants n=3300 Participants

PRIMARY outcome

Timeframe: Up to 12 Months

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

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Amlodipine n=3300 Participants 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.
Number of Participants Who Experience at Least One Adverse Events	286 Participants

PRIMARY outcome

Timeframe: Up to 12 Months

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

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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Amlodipine n=3300 Participants 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.
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	85 Participants

SECONDARY outcome

Timeframe: 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.

Reported data are changes in SBP from baseline at final assessment (up to 12 months).

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Amlodipine n=3246 Participants 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.
Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment	-14.6 mmHg Standard Deviation 19.6

SECONDARY outcome

Timeframe: Baseline and final assessment (up to 12 Months)

Reported data are changes in DBP from baseline at final assessment (up to 12 months).

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Amlodipine n=3246 Participants 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.
Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment	-7.2 mmHg Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline and final assessment (up to 12 Months)

Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Amlodipine n=2259 Participants 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.
Changes From Baseline in Pulse Rate at Final Assessment	-1.2 Beats per minute Standard Deviation 10.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Amlodipine n=3246 Participants 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.
Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment Baseline	28.5 Percentage of Participants
Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment Final Assessment	66.9 Percentage of Participants

Adverse Events

Candesartan Cilexetil/Amlodipine

Serious events: 63 serious events

Other events: 97 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Candesartan Cilexetil/Amlodipine n=3300 participants at risk 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.
Infections and infestations Peritonitis	0.06% 2/3300 • 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.
Infections and infestations Pneumonia	0.18% 6/3300 • 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.
Infections and infestations Pyelonephritis	0.03% 1/3300 • 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.
Infections and infestations Urinary tract infection	0.06% 2/3300 • 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.
Infections and infestations Infectious pleural effusion	0.03% 1/3300 • 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.
Infections and infestations Appendicitis	0.03% 1/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.03% 1/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.06% 2/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 2/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.03% 1/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver carcinoma ruptured	0.03% 1/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 2/3300 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 1/3300 • 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.
Blood and lymphatic system disorders Anaemia	0.03% 1/3300 • 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.
Metabolism and nutrition disorders Dehydration	0.03% 1/3300 • 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.
Metabolism and nutrition disorders Hyperkalaemia	0.03% 1/3300 • 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.
Metabolism and nutrition disorders Marasmus	0.09% 3/3300 • 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.
Psychiatric disorders Completed suicide	0.03% 1/3300 • 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.
Nervous system disorders Cerebral infarction	0.09% 3/3300 • 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.
Nervous system disorders Dementia Alzheimer's type	0.03% 1/3300 • 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.
Nervous system disorders Dizziness	0.03% 1/3300 • 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.
Nervous system disorders Motor neurone disease	0.03% 1/3300 • 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.
Cardiac disorders Acute myocardial infarction	0.03% 1/3300 • 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.
Cardiac disorders Angina pectoris	0.03% 1/3300 • 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.
Cardiac disorders Atrial fibrillation	0.03% 1/3300 • 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.
Cardiac disorders Atrioventricular block complete	0.03% 1/3300 • 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.
Cardiac disorders Cardiac failure	0.09% 3/3300 • 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.
Cardiac disorders Cardiac failure acute	0.03% 1/3300 • 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.
Cardiac disorders Myocardial infarction	0.03% 1/3300 • 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.
Cardiac disorders Myocardial ischaemial	0.03% 1/3300 • 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.
Cardiac disorders Sick sinus syndrome	0.03% 1/3300 • 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.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.03% 1/3300 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.06% 2/3300 • 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.
Gastrointestinal disorders Diverticulitis intestinal haemorrhagic	0.03% 1/3300 • 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.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.03% 1/3300 • 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.
Gastrointestinal disorders Melaena	0.03% 1/3300 • 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.
Hepatobiliary disorders Hepatic Failure	0.03% 1/3300 • 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.
Hepatobiliary disorders Jaundice	0.03% 1/3300 • 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.
Hepatobiliary disorders Liver disorder	0.03% 1/3300 • 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.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.03% 1/3300 • 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.
Musculoskeletal and connective tissue disorders Pathological fracture	0.03% 1/3300 • 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.
Renal and urinary disorders Renal artery stenosis	0.03% 1/3300 • 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.
Renal and urinary disorders Renal disorder	0.03% 1/3300 • 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.
Renal and urinary disorders Renal failure	0.06% 2/3300 • 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.
Renal and urinary disorders Renal failure chronic	0.03% 1/3300 • 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.
Renal and urinary disorders Urinary retention	0.03% 1/3300 • 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.
Renal and urinary disorders Renal impairment	0.03% 1/3300 • 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.
General disorders Death	0.03% 1/3300 • 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.
General disorders Oedema peripheral	0.03% 1/3300 • 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.
Investigations Blood creatinine increased	0.03% 1/3300 • 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.
Investigations Blood pressure decreased	0.03% 1/3300 • 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.
Investigations Blood urea increased	0.03% 1/3300 • 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.
Injury, poisoning and procedural complications Fall	0.06% 2/3300 • 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.
Injury, poisoning and procedural complications Humerus fracture	0.03% 1/3300 • 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.
Injury, poisoning and procedural complications Spinal compression fracture	0.12% 4/3300 • 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.
Injury, poisoning and procedural complications Thermal burn	0.03% 1/3300 • 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.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/3300 • 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.
Injury, poisoning and procedural complications Pubis fracture	0.03% 1/3300 • 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.

Other adverse events

Other adverse events
Measure	Candesartan Cilexetil/Amlodipine n=3300 participants at risk 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.
Hepatobiliary disorders Hepatic function abnormal	0.55% 18/3300 • 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.
Investigations Blood creatinine increased	0.36% 12/3300 • 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.
Investigations Blood pressure decreased	0.64% 21/3300 • 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.
Nervous system disorders Dizziness	0.45% 15/3300 • 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.
Investigations Blood urea increased	0.52% 17/3300 • 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.
Investigations Gamma-glutamyltransferase increased	0.42% 14/3300 • 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.

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