Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)

• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02385721
• Collaborator: (none)
• Enrollment: 601
• Location: 1
• Actual Duration (Months): 59
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension

Detailed Description

This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 601 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension
• Actual Study Start Date: May 1, 2013
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Apr 1, 2018

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing AEs or ADRs [up to 12 months]

   Number of participants experiencing AEs (or ADRs) during the study

Secondary Outcome Measures

1. Treatment Persistence Rate of Fimasartan [up to 12 months]

   Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with essential hypertension

2. Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly

3. Male and female adults aged 20 years or older

4. Voluntarily provided a written consent to participate in the study

Exclusion Criteria:

1. Patients with hypersensitivity to this drug or the ingredients of this drug

2. Pregnant or breast-feeding women

3. Patients on renal dialysis

4. Patients with moderate to severe hepatic impairment

5. Patients with biliary atresia

6. Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption

7. Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator

8. Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yoon Jun Kim	Seoul		Korea, Republic of

Sponsors and Collaborators

• Boryung Pharmaceutical Co., Ltd

Investigators

• Study Director: Myung Sook Hong, Boryung Pharmaceutical Co., Ltd

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 22, 2016

More Information

Publications

None provided.

• Responsible Party: Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT02385721
• Other Study ID Numbers: BR-FMS-PASS-401
• First Posted: Mar 11, 2015
• Last Update Posted: Mar 6, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Boryung Pharmaceutical Co., Ltd: Hypertension; Fimasartan
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

Participant Flow

Arm/Group Title	Safety Set
Arm/Group Description	Patients with essential hypertension who received Kanarb tablet® (fimasartan)
Period Title: Overall Study
STARTED	601
COMPLETED	371
NOT COMPLETED	230

Baseline Characteristics

Arm/Group Title	Safety Set
Arm/Group Description	Patients with essential hypertension who received Kanarb tablet® (fimasartan)
Overall Participants	601
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.65 (11.97)
Sex: Female, Male (Count of Participants)
Female	267 44.4%
Male	334 55.6%
Race and Ethnicity Not Collected (Count of Participants)
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	25.34 (3.31)
Duration of Hypertension (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.47 (8.52)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Experiencing AEs or ADRs
Description	Number of participants experiencing AEs (or ADRs) during the study
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Safety Set
Arm/Group Description	Patients with essential hypertension who received Kanarb tablet® (fimasartan)
Measure Participants	601
AE	184 30.6%
ADR	59 9.8%

2. Secondary Outcome

Title	Treatment Persistence Rate of Fimasartan
Description	Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Safety Set
Arm/Group Description	Patients with essential hypertension who received Kanarb tablet® (fimasartan)
Measure Participants	601
Study completion	371 61.7%
Study withdrawn	230 38.3%

Adverse Events

Time Frame	1 year
Arm/Group Title	Safety Set
Arm/Group Description	Patients with essential hypertension who received Kanarb tablet® (fimasartan)
All Cause Mortality
	Safety Set
	Affected / at Risk (%)	# Events
Total	0/601 (0%)
Serious Adverse Events
	Safety Set
	Affected / at Risk (%)	# Events
Total	33/601 (5.5%)
Blood and lymphatic system disorders
Febrile neutropenia	1/601 (0.2%)	1
Cardiac disorders
Cardiac failure	1/601 (0.2%)	1
Coronary artery stenosis	1/601 (0.2%)	1
Eye disorders
Cataract	1/601 (0.2%)	1
Gastrointestinal disorders
Pancreatitis	1/601 (0.2%)	1
Immune system disorders
Drug hypersensitivity	1/601 (0.2%)	1
Infections and infestations
Appendicitis	1/601 (0.2%)	1
Infective spondylitis	1/601 (0.2%)	1
Injury, poisoning and procedural complications
Clavicle fracture	1/601 (0.2%)	1
Ligament rupture	1/601 (0.2%)	1
Ligament sprain	1/601 (0.2%)	1
Peripheral artery restenosis	1/601 (0.2%)	1
Spinal compression fracture	1/601 (0.2%)	1
Subdural haematoma	1/601 (0.2%)	1
Ulna fracture	1/601 (0.2%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	2/601 (0.3%)	2
Monarthritis	1/601 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma	7/601 (1.2%)	7
Breast cancer	1/601 (0.2%)	1
Laryngeal papilloma	1/601 (0.2%)	1
Femur fracture	1/601 (0.2%)	1
Nervous system disorders
Cerebral infarction	1/601 (0.2%)	1
Haemorrhage intracranial	1/601 (0.2%)	1
Psychiatric disorders
Delirium	1/601 (0.2%)	1
Renal and urinary disorders
Acute kidney injury	2/601 (0.3%)	2
Azotaemia	1/601 (0.2%)	1
Glomerulonephritis membranous	1/601 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/601 (0.2%)	1
Haemoptysis	1/601 (0.2%)	1
Vascular disorders
Aortic dissection	1/601 (0.2%)	1
Varicose vein	1/601 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Safety Set
	Affected / at Risk (%)	# Events
Total	59/601 (9.8%)
Cardiac disorders
Palpitations	1/601 (0.2%)	1
Gastrointestinal disorders
Dyspepsi	2/601 (0.3%)	2
Abdominal pain	1/601 (0.2%)	1
Epigastric discomfort	1/601 (0.2%)	1
General disorders
Asthenia	3/601 (0.5%)	3
Chills	1/601 (0.2%)	1
Fatigue	1/601 (0.2%)	1
Hepatobiliary disorders
Hepatitis	1/601 (0.2%)	1
Hyperbilirubinaemia	1/601 (0.2%)	1
Investigations
Alanine aminotransferase increased	4/601 (0.7%)	4
Blood pressure increased	3/601 (0.5%)	3
Aspartate aminotransferase increased	3/601 (0.5%)	3
Blood pressure decreased	5/601 (0.8%)	5
Liver function test abnormal	1/601 (0.2%)	1
Liver function test increased	1/601 (0.2%)	1
Nervous system disorders
Dizziness	14/601 (2.3%)	15
Headache	7/601 (1.2%)	7
Hypoaesthesia	2/601 (0.3%)	2
Dizziness postural	1/601 (0.2%)	1
Skin and subcutaneous tissue disorders
Urticaria	2/601 (0.3%)	2
Pruritus	3/601 (0.5%)	3
Rash	1/601 (0.2%)	1
Vascular disorders
Blood pressure inadequately controlled	8/601 (1.3%)	8
Hot flush	1/601 (0.2%)	1
Flushing	1/601 (0.2%)	1
Orthostatic hypotension	1/601 (0.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.