Trial Outcomes & Findings for Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension (NCT NCT02248961)

Last Updated: 2019-05-06

Results Overview

The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest. "Change" was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

179 participants

Primary outcome timeframe

Baseline and week 12 of treatment

Results posted on

2019-05-06

Participant Flow

Participants recruitment was conducted in 13 clinical sites of Moscow and Saint-Petersburg between May and October of 2014

Duration of screening period was up to 14 days depended on prior antihypertensive treatment. 184 patients were screened, 179 randomized.

Participant milestones

Participant milestones
Measure	Kanarb (Fimasartan) 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Overall Study STARTED	89	90
Overall Study COMPLETED	86	88
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Kanarb (Fimasartan) 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	2
Overall Study Unmet inclusion/exclusion criteria	1	0

Baseline Characteristics

Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period	Total n=179 Participants Total of all reporting groups
Age, Continuous	53.4 years n=5 Participants	53.8 years n=7 Participants	53.6 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	56 Participants n=7 Participants	115 Participants n=5 Participants
Race/Ethnicity, Customized European	87 Participants n=5 Participants	90 Participants n=7 Participants	177 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
BMI	29.4 kg/m^2 n=5 Participants	28.9 kg/m^2 n=7 Participants	29.1 kg/m^2 n=5 Participants
Arterial hypertension (AH) duration	5.8 years n=5 Participants	6.2 years n=7 Participants	6.0 years n=5 Participants
Hypertension grade Grade I	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants
Hypertension grade Grade II	69 Participants n=5 Participants	63 Participants n=7 Participants	132 Participants n=5 Participants
Chronic heart failure (CHF) NYHA Class I	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Prior therapy for arterial hypertension	55 Participants n=5 Participants	46 Participants n=7 Participants	101 Participants n=5 Participants
Smoking history Smoker	19 Participants n=5 Participants	62 Participants n=7 Participants	81 Participants n=5 Participants
Smoking history Has never smoked	63 Participants n=5 Participants	21 Participants n=7 Participants	84 Participants n=5 Participants
Smoking history Smoker-in-the-past	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Alcohol history Drinking	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
Alcohol history Never-drinking	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Alcohol history Drinking-in-the-past	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Alcohol history Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 12 of treatment

Population: Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment SBP at Baseline	152.9 mm Hg Standard Deviation 5.9	151.9 mm Hg Standard Deviation 5.9
Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment Change from Baseline at Week 12	-25.2 mm Hg Standard Deviation 8.6	-24.3 mm Hg Standard Deviation 7.8

SECONDARY outcome

Timeframe: Baseline and week 4 of treatment

Population: All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4.

The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest. "Change" was calculated as (Value of DBP at week 4 minus Value of SBP at baseline).

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment DBP at Baseline	88.7 mm Hg Standard Deviation 8.1	89.6 mm Hg Standard Deviation 6.9
Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment Change from Baseline at Week 4	-9.5 mm Hg Standard Deviation 9.1	-7.4 mm Hg Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline and week 8 of treatment

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Change in DBP After 8 Weeks of Treatment DBP at Baseline	88.7 mm Hg Standard Deviation 8.1	89.6 mm Hg Standard Deviation 6.9
Change in DBP After 8 Weeks of Treatment Change from Baseline at Week 8	-10.3 mm Hg Standard Deviation 9.5	-10.7 mm Hg Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline and week 12 of treatment

Population: One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 12

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=88 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Change in DBP After 12 Weeks of Treatment DBP at Baseline	88.7 mm Hg Standard Deviation 8.1	89.6 mm Hg Standard Deviation 6.9
Change in DBP After 12 Weeks of Treatment Change from Baseline at Week 12	-10.6 mm Hg Standard Deviation 8.8	-11.3 mm Hg Standard Deviation 7.8

SECONDARY outcome

Timeframe: Baseline and week 4 of treatment

Population: One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Change in SBP After 4 Weeks of Treatment SBP at Baseline	152.9 mm Hg Standard Deviation 5.9	151.9 mm Hg Standard Deviation 5.9
Change in SBP After 4 Weeks of Treatment Change from Baseline at Week 4	-19.7 mm Hg Standard Deviation 10.3	-17.6 mm Hg Standard Deviation 10.5

SECONDARY outcome

Timeframe: Baseline and week 8 of treatment

Population: One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8

The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest. "Change" was calculated as (Value of SBP at week 8 minus Value of SBP at baseline).

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Change in SBP After 8 Weeks of Treatment SBP at Baseline	152.9 mm Hg Standard Deviation 5.9	151.9 mm Hg Standard Deviation 5.9
Change in SBP After 8 Weeks of Treatment Change from Baseline at Week 8	-23.5 mm Hg Standard Deviation 9.0	-23.9 mm Hg Standard Deviation 8.6

SECONDARY outcome

Timeframe: Week 12 of treatment

The subject will be considered a responder if SBP (when seated) \<140 mmHg or SBP decrease is \>10% from baseline.

Outcome measures

Outcome measures
Measure	Kanarb (Fimasartan) n=89 Participants 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 Participants 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Number of Subjects Who Responded on Therapy	85 Participants	90 Participants

Adverse Events

Kanarb (Fimasartan)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Cozaar® (Losartan)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boris Berezhanskiy, Medical Advisor

R-Pharm

Phone: 0074959567937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any study related information could be made public availiable only after Sponsors written permission.
Publication restrictions are in place

Restriction type: OTHER

Measure	Kanarb (Fimasartan) n=89 participants at risk 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period	Cozaar® (Losartan) n=90 participants at risk 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
Blood and lymphatic system disorders Anaemia	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Cardiac disorders Atrial fibrillation	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Eye disorders Conjunctival oedema	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Eye disorders Dry eye	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
General disorders Diarrhoea	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Gastrointestinal disorders Nausea	4.5% 4/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Infections and infestations Bronchitis	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Infections and infestations Nasopharyngitis	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	2.2% 2/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Infections and infestations Pharyngitis	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Infections and infestations Respiratory tract infection viral	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Infections and infestations Rhinitis	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Injury, poisoning and procedural complications Contusion	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Alanine aminotransferase increased	2.2% 2/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Aspartate aminotransferase increased	3.4% 3/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Blood alkaline phosphatase increased	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Blood cholesterol increased	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Blood creatine phosphokinase increased	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Blood pressure increased	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Creatinine renal clearance decreased	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Investigations Low density lipoprotein increased	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Nervous system disorders Dizziness	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Nervous system disorders Headache	4.5% 4/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	3.3% 3/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Renal and urinary disorders Renal impairment	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Skin and subcutaneous tissue disorders Pruritus	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Skin and subcutaneous tissue disorders Urticaria	1.1% 1/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	0.00% 0/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Vascular disorders Hypertensive crisis	0.00% 0/89 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group	1.1% 1/90 • 18 weeks The number and percent of subjects and number and group of AEs will be performed within every organ/system group