Trial Outcomes & Findings for Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) (NCT NCT02385721)
NCT ID: NCT02385721
Last Updated: 2019-03-06
Results Overview
Number of participants experiencing AEs (or ADRs) during the study
Recruitment status
COMPLETED
Target enrollment
601 participants
Primary outcome timeframe
up to 12 months
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Safety Set
Patients with essential hypertension who received Kanarb tablet® (fimasartan)
|
|---|---|
|
Overall Study
STARTED
|
601
|
|
Overall Study
COMPLETED
|
371
|
|
Overall Study
NOT COMPLETED
|
230
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Safety Set
n=601 Participants
Patients with essential hypertension who received Kanarb tablet® (fimasartan)
|
|---|---|
|
Age, Continuous
|
59.65 years
STANDARD_DEVIATION 11.97 • n=601 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=601 Participants
|
|
Sex: Female, Male
Male
|
334 Participants
n=601 Participants
|
|
BMI
|
25.34 kg/m2
STANDARD_DEVIATION 3.31 • n=601 Participants
|
|
Duration of Hypertension
|
6.47 years
STANDARD_DEVIATION 8.52 • n=601 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsNumber of participants experiencing AEs (or ADRs) during the study
Outcome measures
| Measure |
Safety Set
n=601 Participants
Patients with essential hypertension who received Kanarb tablet® (fimasartan)
|
|---|---|
|
Number of Participants Experiencing AEs or ADRs
AE
|
184 Participants
|
|
Number of Participants Experiencing AEs or ADRs
ADR
|
59 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsTreatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study
Outcome measures
| Measure |
Safety Set
n=601 Participants
Patients with essential hypertension who received Kanarb tablet® (fimasartan)
|
|---|---|
|
Treatment Persistence Rate of Fimasartan
Study completion
|
371 Participants
|
|
Treatment Persistence Rate of Fimasartan
Study withdrawn
|
230 Participants
|
Adverse Events
Safety Set
Serious events: 33 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Set
n=601 participants at risk
Patients with essential hypertension who received Kanarb tablet® (fimasartan)
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.2%
7/601 • Number of events 7 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Femur fracture
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
2/601 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Azotaemia
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.33%
2/601 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Infections and infestations
Infective spondylitis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral infarction
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic dissection
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Vascular disorders
Varicose vein
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Eye disorders
Cataract
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Immune system disorders
Drug hypersensitivity
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.17%
1/601 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Safety Set
n=601 participants at risk
Patients with essential hypertension who received Kanarb tablet® (fimasartan)
|
|---|---|
|
Nervous system disorders
Dizziness
|
2.3%
14/601 • Number of events 15 • 1 year
|
|
Nervous system disorders
Headache
|
1.2%
7/601 • Number of events 7 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
0.33%
2/601 • Number of events 2 • 1 year
|
|
Nervous system disorders
Dizziness postural
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.67%
4/601 • Number of events 4 • 1 year
|
|
Investigations
Blood pressure increased
|
0.50%
3/601 • Number of events 3 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.50%
3/601 • Number of events 3 • 1 year
|
|
Investigations
Blood pressure decreased
|
0.83%
5/601 • Number of events 5 • 1 year
|
|
Investigations
Liver function test abnormal
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Investigations
Liver function test increased
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Dyspepsi
|
0.33%
2/601 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
General disorders
Asthenia
|
0.50%
3/601 • Number of events 3 • 1 year
|
|
General disorders
Chills
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.33%
2/601 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.50%
3/601 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Vascular disorders
Blood pressure inadequately controlled
|
1.3%
8/601 • Number of events 8 • 1 year
|
|
Vascular disorders
Hot flush
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Vascular disorders
Flushing
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Vascular disorders
Orthostatic hypotension
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatitis
|
0.17%
1/601 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.17%
1/601 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place