Trial Outcomes & Findings for Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients (NCT NCT00922480)
NCT ID: NCT00922480
Last Updated: 2018-04-10
Results Overview
Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
506 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2018-04-10
Participant Flow
Participant milestones
| Measure |
Control: Losartan
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
|---|---|---|
|
Main Study
STARTED
|
250
|
255
|
|
Main Study
COMPLETED
|
213
|
226
|
|
Main Study
NOT COMPLETED
|
37
|
29
|
|
Extension Study
STARTED
|
73
|
85
|
|
Extension Study
COMPLETED
|
68
|
82
|
|
Extension Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Control: Losartan
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
|---|---|---|
|
Main Study
Protocol Violation
|
3
|
6
|
|
Main Study
Adverse Event
|
6
|
7
|
|
Main Study
Lack of Efficacy
|
3
|
0
|
|
Main Study
Withdrawal by Subject
|
20
|
15
|
|
Main Study
Lost to Follow-up
|
5
|
0
|
|
Main Study
Physician Decision
|
0
|
1
|
|
Extension Study
Protocol Violation
|
3
|
0
|
|
Extension Study
Adverse Event
|
1
|
1
|
|
Extension Study
Withdrawal by Subject
|
1
|
1
|
|
Extension Study
Others
|
0
|
1
|
Baseline Characteristics
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
Baseline characteristics by cohort
| Measure |
Control: Losartan
n=238 Participants
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan
n=247 Participants
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
Total
n=485 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.58 years
STANDARD_DEVIATION 9.61 • n=93 Participants
|
53.96 years
STANDARD_DEVIATION 8.79 • n=4 Participants
|
53.77 years
STANDARD_DEVIATION 9.19 • n=27 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
150 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=93 Participants
|
168 Participants
n=4 Participants
|
335 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.
Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position
Outcome measures
| Measure |
Control: Losartan / Week 12 -ITT
n=238 Participants
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan / Week 12 -ITT
n=247 Participants
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
|---|---|---|
|
Diastolic Blood Pressure Change
|
-8.56 mmHg
Standard Deviation 7.72
|
-11.26 mmHg
Standard Deviation 7.53
|
SECONDARY outcome
Timeframe: baseline and 4 weeks, 8 weeksPopulation: As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.
* Value of DBP at 4 Weeks minus value of DBP at Baseline while in a sitting position * Value of DBP at 8 Weeks minus value of DBP at Baseline while in a sitting position
Outcome measures
| Measure |
Control: Losartan / Week 12 -ITT
n=238 Participants
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan / Week 12 -ITT
n=247 Participants
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
|---|---|---|
|
Diastolic Blood Pressure Change
Week 4
|
-5.73 mmHg
Standard Deviation 6.56
|
-8.22 mmHg
Standard Deviation 7.35
|
|
Diastolic Blood Pressure Change
Week 8
|
-8.01 mmHg
Standard Deviation 7.16
|
-11.01 mmHg
Standard Deviation 7.63
|
Adverse Events
Control: Losartan
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Test: Fimasartan
Serious events: 3 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control: Losartan
n=250 participants at risk
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan
n=255 participants at risk
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Appendicitis
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Cardiac disorders
coronary artery occlusion
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Multiple fracture
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
Other adverse events
| Measure |
Control: Losartan
n=250 participants at risk
Losartan group
Losartan (Control): Losartan 50 mg \~ 100 mg/po, take one tablets once a day
|
Test: Fimasartan
n=255 participants at risk
Fimasartan 60mg, 120mg
Fimasartan: Fimasartan 60 \~ 120mg/po take one tablets once a day
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.8%
17/250 • Number of events 18
|
6.3%
16/255 • Number of events 17
|
|
Nervous system disorders
Dizziness
|
3.6%
9/250 • Number of events 10
|
4.3%
11/255 • Number of events 11
|
|
Nervous system disorders
Hypoaesthesia
|
0.80%
2/250 • Number of events 2
|
0.00%
0/255
|
|
Nervous system disorders
Migraine
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Nervous system disorders
Dysaesthesia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Nervous system disorders
Dysarthria
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Nervous system disorders
Somnolence
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Nervous system disorders
Syncope
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
5/250 • Number of events 5
|
0.78%
2/255 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.6%
4/250 • Number of events 4
|
0.78%
2/255 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.40%
1/250 • Number of events 1
|
1.2%
3/255 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
4/250 • Number of events 4
|
0.00%
0/255
|
|
Gastrointestinal disorders
Vomiting
|
0.40%
1/250 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Dental caries
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Palatal oedema
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
5/250 • Number of events 6
|
3.1%
8/255 • Number of events 8
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
3/250 • Number of events 3
|
2.0%
5/255 • Number of events 5
|
|
Infections and infestations
Rhinitis
|
1.2%
3/250 • Number of events 3
|
0.00%
0/255
|
|
Infections and infestations
Bronchitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Cystitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Herpes zoster
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Otitis media
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Infections and infestations
pharyngitis
|
0.40%
1/250 • Number of events 1
|
0.39%
1/255
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.80%
2/250 • Number of events 2
|
0.78%
2/255 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pelvic deformity
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.40%
1/250 • Number of events 1
|
1.6%
4/255 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
0.40%
1/250 • Number of events 1
|
1.6%
4/255 • Number of events 4
|
|
Investigations
Blood urine present
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Investigations
Glucose urine present
|
0.80%
2/250 • Number of events 2
|
0.00%
0/255
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Investigations
Spinal X-ray abnormal
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
General disorders
Chest discomfort
|
1.2%
3/250 • Number of events 3
|
1.2%
3/255 • Number of events 3
|
|
General disorders
Chest pain
|
0.80%
2/250 • Number of events 2
|
0.78%
2/255 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
General disorders
Face oedema
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
General disorders
Fatigue
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
3/250 • Number of events 3
|
1.6%
4/255 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.40%
1/250 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria localised
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/250
|
1.2%
3/255 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Cardiac disorders
Palpitations
|
0.80%
2/250 • Number of events 2
|
1.2%
3/255 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
0.80%
2/250 • Number of events 2
|
0.00%
0/255
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.80%
2/250 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/250
|
0.78%
2/255 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Eye disorders
Blepharospasm
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Eye disorders
Eyelid ptosis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.40%
1/250 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Psychiatric disorders
insomnia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Vascular disorders
Flushing
|
0.80%
2/250 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/250
|
0.39%
1/255 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place